Integrase inhib 
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374 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Isentress (raltegravir) / Merck (MSD)
ACTRN12609000881235: A randomised open-label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2-3 nucleoside reverse transcriptase inhibitors (NRTI) backbone versus ritonavir boosted lopinavir and raltegravir in participants virologically failing first-line non-nucleoside reverse transcriptase inhibitors (NNRTI)/2 NRTI therapy (the SECOND-LINE study). This study is for Human Immunodeficiency Virus (HIV) infection.

Active, not recruiting
4
550
 
University of New South Wales/Kirby Institute, University of New South Wales/Kirby Institute, Abbott, Merck Sharpe & Dohme, amfAR
Human Immunodeficiency Virus (HIV) -1 infection
 
 
2011-005270-35: Study of the effect of pregnancy on the concentrations of antiretroviral drugs in the blood of women with HIV infection Studio dell'effetto della gravidanza sulle concentrazioni dei farmaci antiretrovirali nel sangue di donne con infezione da HIV

Ongoing
4
120
Europe
Tablet, Capsule, soft, Capsule, hard, Film-coated tablet, VIRAMUNE*60CPR 200MG, COMBIVIR*FL 60CPR RIV, KALETRA*120CPR RIV 200MG+50MG, REYATAZ*60CPS 150MG, TRUVADA*30CPR RIV 200MG/245MG, PREZISTA*60CPR RIV 600MG, ISENTRESS*FL 60CPR RIV 400MG, NORVIR*FL 84CPS MOLLI 100MG
ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI, Istituto Superiore di Sanita'
HIV-1 infection Infezione da HIV-1, HIV infection Infezione da HIV, Diseases [C] - Virus Diseases [C02]
 
 
2014-003710-84: The CNS Integrase Inhibitor Study

Ongoing
4
22
Europe
Tivicay, Isentress, Truvada, Film-coated tablet, Tivicay, Isentress, Truvada
Imperial College London
Human Immunodificiency Virus, HIV, Diseases [C] - Virus Diseases [C02]
 
 
2015-000274-35: clinical trial to assess the safety, tolerability and efficacy of two dolutegravir-based simplification strategies in HIV-infected patients with prolonged virological suppression. ENSAYO CLÍNICO PARA EVALUAR LA SEGURIDAD, TOLERABILIDAD Y EFICACIA DE DOS ESTRATEGIAS DE SIMPLIFICACIÓN BASADAS EN DOLUTEGRAVIR EN PACIENTES INFECTADOS POR VIH CON SUPRESIÓN VIROLÓGICA SOSTENIDA.

Ongoing
4
450
Europe
Lamivudine, Efavirenz, nevirapine, J05AX12, Coated tablet, Capsule, hard, Tablet, Prolonged-release tablet, Tivicay, Stribild, TRUVADA, KIVEXA, ZIAGEN, VIREAD, EMTRIVA, ATRIPLA, EVIPLERA, ISENTRESS, RAYATAZ, PREZISTA, KALETRA, NORVIR, INTELENCE, EDURANT, TRIUMEQ
Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA
Infection with human immunodeficiency virus (HIV). Infección por el virus de la inmunodeficiencia humana (VIH)., HIV infection Infección por VIH, Diseases [C] - Virus Diseases [C02]
 
 
2008-001611-38: Estudio piloto prospectivo de la farmacocinética y farmacodinamia de la interaciión entre tipranavir/ritonavir y raltegravir en pacientes infectados por el VIH-1

Ongoing
4
10
Europe
Isentress, Aptivus, Norvir, raltegravir, tipranavir, ritonavir, Isentress, Aptivus, Norvir, Isentress, Aptivus, Norvir
Jose M Gatell - Hospital Clinic de Barcelona
Pacientes con infección crónica por VIH-1
 
 
2009-013679-23: étude cas-témoins comparant l\'efficacité d’une combinaison thérapeutique contenant l\'inhibiteur de l\'intégrase raltégravir (400 mg x 2) ou une combinaison thérapeutique ne contenant pas le raltégravir sur la diminution de l\'ADN proviral chez des sujets prétraités présentant une infection par le VIH-1 avec une charge virale détectable

Ongoing
4
60
Europe
Raltegravir, J05AX08, Raltegravir, Raltegravir
STOP SIDA
Patients âgés de plus de 18 ans, infectés par le VIH et traités par Raltégravir.
 
 
2014-004578-40: SSAT 066 Renal Integrase Study

Not yet recruiting
4
60
Europe
Tivicay 50 mg film - coated tablets, Isentress 400 mg Film-coated Tablets, Truvada 200 mg/245 mg film-coated tablets, Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets, Film-coated tablet, Tivicay 50 mg film-coated tablets, Isentress 400 mg Film-coated Tablets, Truvada 200 mg/245 mg film-coated tablets, Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets
St Stephen's AIDS Trust, Merck, Sharp & Dohme Limited
HIV
 
 
2016-000437-43: The time to protection and adherence requirements of Raltegravir with or without lamivudine in protection from HIV infection

Not yet recruiting
4
36
Europe
Raltegravir, Lamivudine, Tablet, Film-coated tablet, Raltegravir, Lamivudine
Guy's and St Thomas NHS Foundation Trust, Merck Sharp & Dhome Ltd
HIV, HIV, Diseases [C] - Virus Diseases [C02]
 
 
2017-004750-42: EFFICACY AND SAFETY OF A SIMPLIFICATION TREATMENT BASED ON DOLUTEGRAVIR AND DARUNAVIR / COBICISTAT VS USUAL TREATMENT IN SUPPRESSED HIV-1-INFECTED PATIENTS WITH MULTIDRUG RESISTANCE. Eficacia y seguridad de Dolutegravir más Darunavir/cobicistat como tratamiento de simplificación frente al tratamiento habitual en pacientes infectados por el VIH-1 virológicamente suprimidos y con resistencia a múltiples fármacos.

Ongoing
4
100
Europe
lamivudine, Efavirenz, Nevirapine, Film-coated tablet, Coated tablet, Capsule, hard, Tablet, Rezolsta, Tivicay, Ziagen, EMTRIVA, VIREAD, kivexa, Truvada, Intelence, Edurant, Atripla, Eviplera, Reyataz, Prezista, Kaletra, Norvir, Evotaz, Isentress, Stribild, Triumeq, Genvoya, Celsentri, Descovy
FUNDACIÓ LLUITA CONTRA LA SIDA, ViiV Healthcare
HIV-1 VIH-1, HIV infection Infección por VIH, Diseases [C] - Virus Diseases [C02]
 
 
2017-003470-14: Raltegravir One Thousand two hundred vs Darunavir-cb in Immnunosupressed Patients: ROTDIP Study Raltegravir 1200 versus Darunavir-cb en pacientes inmunodeprimidos: estudio ROTDIP

Not yet recruiting
4
75
Europe
Film-coated tablet, , ISENTRESS
FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud, APES Costa del Sol (Agencia Pública Empresarial Sanitaria Costa del Sol), MSD Merck Sharp & Dohme, MSD MErck Sharp & Dohme
Human Immunodeficiency Virus (HIV) infection Infección por el Virus de Inmunodeficiencia Humana (VIH), Human Immunodeficiency Virus (HIV) infection Infección por el Virus de Inmunodeficiencia Humana (VIH)., Diseases [C] - Virus Diseases [C02]
 
 
NCT04258475: The Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir.

Recruiting
4
12
Canada
Raltegravir standard dosage of 1200 mg (two 600 mg tablets) orally once daily., RAL, Isentress®, Calcium carbonate antacid tablet, TUMS® Ultra Strength (US) 500 mg
Ottawa Hospital Research Institute
Calcium Supplementation in HIV Patients Using Raltegravir
06/24
01/25
PANNA-B PK, NCT05648201: Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers

Recruiting
4
36
Europe
Doravirine 100Mg Tab, pifeltro, Raltegravir 600Mg Tab, issentres, Biktarvy 50/200/25 Tab, biktarvy
Radboud University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development, Merck Sharp & Dohme LLC
Hiv
11/24
12/24
ACTRN12609000575235: Antiretroviral therapy intensification with raltegravir and/or hyper-immune bovine colostrum in Human Immunodeficiency Virus-1 (HIV-1) infected patients with suboptimal immunological response

Active, not recruiting
3/4
72
 
University of New South Wales (UNSW), National Centre in HIV Epidemiology and Clinical Research University of New South Wales (UNSW)
Human Immunodeficiency Virus (HIV)Infection
 
 
NCT00717964: Study of Raltegravir Versus Nucleotide Reverse Transcriptase Inhibitors (NRTIs) as a Backbone in HIV-Infected Subjects Switched From a Stable Boosted Protease Inhibitor (PI) Regimen

Active, not recruiting
3
34
US
Raltegravir, Isentress, current antiretroviral regimen
St. Joseph's Hospital, Florida
HIV Infections
07/11
10/11
2007-000783-25: A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus KALETRA™ in HIV-Infected Patients Switched from a Stable KALETRA™-Based Regimen - Study A

 
3
32
Europe
Kaletra (Lopinavir Ritonavir), MK-0518, KALETRA, KALETRA
Merck Sharp & Dohme de España, S.A., Merck & Co., Inc., Merck Sharp & Dohme Limited, MERCK SHARP DOHME, Merck Sharp & Dohme, Lda.
HIV Infection
 
12/08
2008-002733-70: A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK-0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients

 
3
65
Europe
ISENTRESS, TRUVADA, MK-0518, ISENTRESS, TRUVADA, ISENTRESS, TRUVADA
Merck & Co., Inc., Merck & Co Inc.,, Merck & Co. Inc., Laboratoires Merck Sharp & Dhome-Chibret, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., MERCK & CO., INC., MSD BV
HIV infection
 
05/11
2010-018878-21: A phase III, open-label, single centre, single-arm, pilot study to assess the feasibility of switching, individuals receiving efavirenz with continuing Central Nervous System (CNS) toxicity, to raltegravir

Ongoing
3
40
Europe
Isentress, Truvada (tenofovir disoproxil/emtricitabine), Isentress, Truvada, Isentress, Truvada
St Stephen\'s AIDS Trust
HIV
 
 
2019-001961-34: ANRS 173 ALTAR (ALlégement du Traitement AntiRétroviral) ANRS 173 ALTAR (ALlégement du Traitement AntiRétroviral)

Not yet recruiting
3
360
Europe
Film-coated tablet, , VIREAD or Tenofovir disoproxil fumarate (generic drug), STRIBILD 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir), BIKTARVY bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide., ISENTRESS, TIVICAY, DESCOVY 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide, GENVOYA 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide, EPIVIR or Lamivudine (generic drugs), TRUVADA or Emtricitabine and tenofovir disoproxil fumarate (Generic drug)
INSERM ANRS, ANRS
Hiv Infection Infection par le VIH, Hiv Infection Infection par le VIH, Diseases [C] - Virus Diseases [C02]
 
 
2008-004970-41: Phase II open-label randomized multicenter trial to compare the efficacy and safety of two different doses of raltegravir and efavirenz, all in combination with tenofovir and lamivudine, in naive HIV-1-infected patients receiving rifampin for active tuberculosis.

Ongoing
2
15
Europe
Sustiva, Viread, Epivir, MK-0518, BMS-561525, raltegravir, Sustiva, Viread, Epivir, Isentress, Sustiva, Viread, Epivir, Isentress
Agence nationale de recherches sur le sida et les hépatites virales. ANRS.
HIV-1 Infection and tuberculosis
 
 
2009-016480-11: “No Nuc, No Boost” : A phase 2 pilot study of simplification by Maraviroc-Raltegravir following 6 months of treatment with Maraviroc-Raltegravir-Tenofovir-Emtricitabine in naive patients infected by CCR5 HIV-1

Ongoing
2
40
Europe
Raltegravir, Maraviroc, Tenofovir/Emtricitabine, ISENTRESS, CELSENTRI, TRUVADA, ISENTRESS, CELSENTRI, TRUVADA
P Pierre Dellamonica
HIV naïve patients, CCR5 tropism, with CD4 > 200/mm3 and HIV RNA < 100 000 copy/ml.
 
 
2009-014406-34: International, multicenter, randomized, non-comparative controlled study of therapeutic intensification plus immunomodulation in HIV patients with long-term viral suppression

Ongoing
2
12
Europe
GLYCOSYLATED RECOMBINANT HUMAN INTERLEUKIN-7, MARAVIROC, RALTEGRAVIR, CYT107, SELZENTRY, CELSENTRI, ISENTRESS, SELZENTRY, CELSENTRI, ISENTRESS
ORVACS, KEYRUS BIOPHARMA, , Bettencourt-Schueller Foundation
HIV-1 Infection
 
 
RIVER, NCT02336074 / 2014-001425-32: Research In Viral Eradication of HIV Reservoirs

Completed
2
60
Europe
Combination Antiretroviral Therapy (cART), Raltegravir, Isentress, Vorinostat, ChAdV63.HIVconsv (ChAd), MVA.HIVconsv (MVA)
Imperial College London, Medical Research Council, University of Oxford, University of Cambridge, Chelsea and Westminster NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Central and North West London NHS Foundation Trust
HIV
11/17
03/23
2019-004195-19: A randomized comparative phase II trial evaluating the capacity of the dual combination doravirine/raltegravir to maintain virological success in HIV-1 infected patients with an HIV-RNA plasma viremia below 50 copies/mL under a current antiretroviral regimen

Not yet recruiting
2
150
Europe
Isentress, Pifeltro, J05AX08, J05AR24, Tablet, ISENTRESS, Pifeltro
Centre de Recherche et d’Etudes sur la Pathologie Tropicale et le Sida (CREPATS), Centre de Recherche et d’Etudes sur la Pathologie Tropical et le Sida (CREPATS), CREPATS, Centre de Recherche et d’Etudes sur la Pathologie Tropical et le Sida (CREPATS)
HIV disease, HIV disease, Diseases [C] - Virus Diseases [C02]
 
 
NCT03954327: Combination Antiretroviral Therapy (cART) for PBC

Completed
2
37
Canada
Emtricitabine (FTC)/Tenofovir Disoproxil (TDF), Truvada, Raltegravir, Isentress, Placebo Oral Capsule [CEBOCAP], placebo
University of Alberta, Merck Sharp & Dohme LLC
Primary Biliary Cholangitis
10/22
01/24
DORAL, NCT04513626: HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label

Recruiting
2
150
Europe
DORAVIRINE 100 MG [Pifeltro], Raltegravir 600 Mg x 2 [Isentress]
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
HIV Infections
10/25
10/25
NCT02140255: Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Recruiting
1/2
1120
US, RoW
Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Nevirapine (NVP), Lopinavir/Ritonavir (LPV/r), Raltegravir (RAL), VRC01, DTG, VRC07-523LS
National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
HIV Infection
01/28
12/31
NCT03174977: Pharmacokinetics Distribution of Raltegravir by PET/MR

Recruiting
1
10
US
18F-Raltegravir
University of California, San Francisco, Merck Sharp & Dohme LLC
HIV-1-infection
11/24
01/25
POPARV, NCT03194165: Population Pharmacokinetics of Antiretroviral in Children

Completed
N/A
65
Europe
Dolutegravir, Raltegravir, Rilpivirine, Nevirapine, Atazanavir, Darunavir, Ritonavir
Assistance Publique - Hôpitaux de Paris
Minor Patient Treated by One or More Antiretroviral and for Which a Blood Test Has Been Performed
06/22
06/22
RalAge2, NCT03579485: An Observational Retrospective Database Analysis to Evaluate Raltegravir Based-regimens, Including NUC-sparing Regimens, in Aged HIV Patients.(RalAge)

Recruiting
N/A
90
Europe
Azienda Policlinico Umberto I
Hiv
12/23
12/24
EPPICC, NCT05751031: Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration

Recruiting
N/A
1200
Europe, RoW
Raltegravir
Fondazione Penta UK, UCL Great Ormond Street Institute of Child Health
HIV Infections
02/24
02/24
NCT00537966: Characterization of Acute and Recent HIV-1 Infections in Zurich.

Recruiting
N/A
800
Europe
Dolutegravir, Tivicay, Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamid Fumarate, Genvoya, Raltegravir, isentress, Darunavir, Prezista, Ritonavir, Norvir, Rilpivirine, Edurant, Lamivudine, 3TC, tenofovir, Viread, Emtricitabine, Emtriva, Abacavir, Ziagen
University of Zurich
HIV Infections
12/28
12/28
ACTRN12608000177358: An open label study to examine the characteristics of Human Immunodeficiency Virus (HIV) decay following introduction of combination antiretroviral therapy including raltegravir during primary and chronic HIV infection

Active, not recruiting
N/A
16
 
National Centre in HIV Epidemiology and Clinical Research, National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales (UNSW), Merck, Sharp and Dohme
Primary HIV (acute or early), Chronic HIV infection
 
 
Vocabria (cabotegravir oral) / ViiV Healthcare
PILLAR, NCT05374525: A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States

Completed
4
201
US
APRETUDE, Cabotegravir OLI
ViiV Healthcare
HIV Infections
08/24
08/24
EBONI, NCT05514509: A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

Active, not recruiting
4
66
US
APRETUDE, Cabotegravir tablet
ViiV Healthcare
HIV Infections
09/25
09/25
Tshireletso, NCT05986084: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana

Recruiting
4
500
US, RoW
Cabotegravir Injection [Apretude]
Beth Israel Deaconess Medical Center, Botswana Harvard AIDS Institute Partnership, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), ViiV Healthcare
Pre-Exposure Prophylaxis (PrEP), Breast Feeding
08/27
08/27
ATLAS-2M, NCT03299049 / 2017-002946-62: Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

Active, not recruiting
3
1049
Europe, Canada, US, RoW
Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir Injectable Suspension, Rilpivirine Injectable Suspension
ViiV Healthcare, Janssen Research and Development
HIV Infections
06/19
12/25
HPTN 084, NCT03164564: Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

Active, not recruiting
3
3224
RoW
Oral CAB, Cabotegravir, Oral TDF/FTC, Tenofovir disoproxil fumarate/emtricitabine, Truvada, Placebo for oral CAB, Placebo for oral TDF/FTC, CAB LA, Cabotegravir long-acting injectable, Placebo for CAB LA
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
11/20
11/24
SOLAR, NCT04542070 / 2020-002623-11: A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

Completed
3
687
Europe, Canada, Japan, US, RoW
Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA), Rilpivirine Tablets, Rilpivirine Injectable Suspension (RPV LA), BIKTARVY Tablets (BIK)
ViiV Healthcare, Janssen, LP
HIV Infections
07/22
04/23
NCT05896761: A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants

Completed
3
118
Europe, Canada, US, RoW
Cabotegravir Injectable Suspension, Rilpivirine Injectable Suspension
ViiV Healthcare, Janssen Research and Development
Human Immunodeficiency Virus Type 1 (HIV-1)
08/22
08/22
NCT05896748: Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study

Completed
3
94
Europe, Canada, Japan, US, RoW
Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA)
ViiV Healthcare, Janssen Pharmaceuticals, GlaxoSmithKline
Human Immunodeficiency Virus Type 1 (HIV-1)
09/23
09/23
LAPIS, NCT06250504: Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT

Recruiting
3
2000
RoW
APRETUDE (cabotegravir) 600 mg\3 mL, DAPIRING (Dapivirine) 25mg Vaginal Ring, tenofovir disoproxil and emtricitabine, Tenofovir Disoproxil, Lamuvidine and Dolutegravir
Africa Health Research Institute
HIV Infections
07/25
03/26
CABOPrEP, NCT06273943: Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.

Not yet recruiting
3
322
Europe
Cabotegravir Tablets, for oral use., VOCABRIA, Cabotegravir Extended-Release Injectable Suspension, for intramuscular use., APRETUDE, Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use, TRUVADA, Rectal Biopsies
ANRS, Emerging Infectious Diseases
Prevention
10/25
10/26
MOBILEMEN, NCT06133686: Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa

Not yet recruiting
3
400
NA
Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA), Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC)
MRC/UVRI and LSHTM Uganda Research Unit, King's College London, London School of Hygiene and Tropical Medicine, Africa Health Research Institute, Wits Health Consortium (Pty) Ltd, University College, London, Ministry of Health, Uganda, Desmond Tutu HIV Foundation, Assistance Publique - Hôpitaux de Paris
HIV
12/25
04/27
NCT03635788: The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE

Active, not recruiting
3
456
US
Standard of Care (SOC) Oral ART, Oral RPV, Rilpivirine, Oral CAB, Cabotegravir, GSK1265744, RPV-LA Loading Dose, Rilpivirine Long-Acting Injectable, CAB-LA Loading Dose, Cabotegravir Long-Acting Injectable, RPV-LA Maintenance Dose, CAB-LA Maintenance Dose
National Institute of Allergy and Infectious Diseases (NIAID), ViiV Healthcare
HIV Infections
02/24
08/26
VOLITION, NCT05917509: A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

Active, not recruiting
3
171
Europe, Canada, US, RoW
DTG/3TC, Dovato, Cabotegravir (CAB) LA, Vocabria, Rilpivirine (RPV) LA, Rekambys
ViiV Healthcare, GlaxoSmithKline, PPD DEVELOPMENT, LP
HIV Infections
10/25
10/26
LATTE-2, NCT02120352 / 2013-000783-29: A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects

Completed
2
309
Europe, Canada, US
CAB Oral Tablets, CAB LA, ABC/3TC Oral tablets, RPV Oral Tablets, HAART, RPV
ViiV Healthcare, Janssen Pharmaceuticals, GlaxoSmithKline
Infection, Human Immunodeficiency Virus, HIV Infections
08/15
04/23
NCT04824131: Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females

Completed
2
55
RoW
Oral cabotegravir (CAB), CAB LA, Oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)
National Institute of Allergy and Infectious Diseases (NIAID), ViiV Healthcare, Bill and Melinda Gates Foundation
HIV Infections
01/23
01/23
NCT04692077: Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males

Completed
2
9
US
Cabotegravir (CAB) tablet, CAB LA, Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
07/23
07/23
EMBRACE, NCT05996471: A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

Active, not recruiting
2
135
US
VH3810109, Cabotegravir, Standard of care (SOC), rHuPH20
ViiV Healthcare
HIV Infections
11/24
01/29
NCT01215006: A Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects

Active, not recruiting
1
48
US
GSK1265744 injectable suspension, Placebo to match injectable suspension
GlaxoSmithKline, ViiV Healthcare
Infections, Human Immunodeficiency Virus and Herpesviridae, HIV Infection
05/12
05/12
NCT04484337: Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants

Completed
1
138
US, RoW
Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL, Cabotegravir 200 mg/mL, Topical non-steroidal anti-inflammatory drug, Topical steroid, Placebo creams/gels, Recombinant human hyaluronidase PH20 (rHuPH20)
ViiV Healthcare
HIV Infections
05/23
05/23
NCT05776108: A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation

Completed
1
24
US
Cabotegravir IR Formulation (reference), Cabotegravir DT Formulation (test 1), Cabotegravir DT Formulation (test 2)
ViiV Healthcare
HIV Infections
06/23
06/23
NCT05418868: A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

Recruiting
1
180
US
Cabotegravir 200 mg/mL, Cabotegravir >=400 mg/mL, Cabotegravir Formulation I, rHuPH20, RPV
ViiV Healthcare, GlaxoSmithKline, Janssen Sciences Ireland Unlimited Company
HIV Infections
07/26
11/27
NCT05112939: A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants

Completed
1
126
Europe, US
RPV LA, TMC278, CAB LA, GSK1265744
Janssen Research & Development, LLC
Healthy
05/24
05/24
NCT06033547: A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants

Active, not recruiting
1
56
US
Cabotegravir Formulation F, Cabotegravir Formulation G
ViiV Healthcare
HIV Infections
06/25
06/25
NCT03462810: GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV

Available
N/A
NA
cabotegravir, CAB, cabotegravir, CAB
ViiV Healthcare
Infection, Human Immunodeficiency Virus
 
 
NCT06405464: Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures

Recruiting
N/A
600
Europe
VOCABRIA 30Mg Tablet, Cabotegravir Tablets, EDURANT 25Mg Tablet, Rilpivirine Tablets, Cabotegravir Injectable Suspension, Vocabria, Rilpivirine Injectable Suspension, Rekambys, Intact proviral DNA assay, Full-length sequencing
University of Zurich, Swiss HIV Cohort Study
HIV Infections
12/25
06/26
NCT06643897: Identification of Barriers and Facilitators of Implementation of the Out-of-Hospital Administration of the Long- Acting Combination Cabotegravir+Rilpivirina.

Completed
N/A
13
Europe
Qualitative Interview
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
HIV-1-infection
10/24
10/24
SCohoLART, NCT05663580: Cohort Study of HIV-positive People, Treated with Long Acting Antiretroviral Therapy

Recruiting
N/A
1500
Europe
Cabotegravir 600mg/3mL, Rilpivirine 900mg/3mL
Castagna Antonella
HIV Infections
07/24
07/27
CHEERS, NCT06565013: Chemsex Health Evaluation With Extended Release System for HIV Treatment

Not yet recruiting
N/A
50
Canada
Cabenuva 600/900, Self administered questionnaires, Semi-directed interview
Clinique Médicale L'Actuel, ViiV Healthcare
HIV
02/26
02/26
NCT06704204: Long-acting Injectable Antiretroviral Treatment to Improve HIV Treatment Among Justice-involved Persons Being Released to the Community

Not yet recruiting
N/A
20
NA
The first FDA-approved LAI ART regimen includes an integrase inhibitor, cabotegravir (CAB), and a non-nucleoside reverse transcriptase inhibitor, rilpivirine (RPV) combined 4 wks
The Miriam Hospital, National Institute on Drug Abuse (NIDA)
HIV
07/25
07/25
ChiCTR2400089435: Evaluation of 28-week Antiretroviral Treatment with Albuvirtide and Cabotegravir in HIV Patients with Stable Virologic Suppression: Efficacy, Pharmacokinetics, and Safety

Not yet recruiting
N/A
10
 
Albuvirtide combined with Categlusevir
Guangzhou Eighth Peoples Hospital Guangzhou Medical University; Guangzhou Eighth Peoples Hospital Guangzhou Medical University, self-financing
HIV/AIDS
 
 
NCT04518228: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Active, not recruiting
N/A
205
US, RoW
Bictegravir (BIC), Tenofovir alafenamide (TAF), Cabotegravir (CAB), Dolutegravir (DTG), Atazanavir/ritonavir (ATV/r), Darunavir/ritonavir (DRV/r), Lopinavir/ritonavir (LPV/r), Cobicistat, Ritonavir, First-Line TB Treatment, Second-Line TB Treatment, Doravirine (DOR)
National Institute of Allergy and Infectious Diseases (NIAID), International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), Gilead Sciences, ViiV Healthcare, Merck Sharp & Dohme LLC
HIV Infections, Tuberculosis
03/26
03/26
Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
2014-002281-70: Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV-1?infected patients (<100 CD4+ T cells/?L) taking antiretroviral regimens based on dolutegravir or ritonavir-boosted darunavir (the AdvanZ-4 Trial). Reconstitución inmune en pacientes con infección por el VIH-1 no tratados previamente y con cifras de linfocitos CD4+ inferiores a 100 céls/mm3 que reciben un régimen de fármacos antirretrovirales basado en dolutegravir o darunavir/ritonavir. Estudio AdvanZ-4.

Ongoing
4
108
Europe
CoatedTablet600 mg de abacavir ( sulfate) 300 mg de lamivudine, PREZISTA 300 mg comprimidos recubiertos con película darunavir, Norvir 100 mg soft tablets, Triumeq, Coated tablet, Capsule, soft, Tablet, KIVEXA( Abacavir 600 mg/ Lamivudine 300 mg) recovered tablets, PREZISTA 300 mg recovered Tablets, NORVIR 100 mg soft Tablets, TRIUMEQ®: Lamivudine(3TC) 300 mg+ Abacavir(ABC) 600 mg + dolutegravir(DGT) 50 mg : 1 comprimido
Fundació Clínic per a la Recerca Biomèdica, ViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex TW8 9GS Reino Unido
tratement HIV infection tratamiento de la infección por HIV, HIV infection infección por HIV, Diseases [C] - Virus Diseases [C02]
 
 
2015-005297-37: Bone Evaluation in women over 40 who Switch from Truvada/NNRTI to Triumeq

Ongoing
4
90
Europe
Tenofovir, Lamivudine, Efavirenz, Nevirapine, Etravirine, Rilpivirine, Film-coated tablet, Tablet, Triumeq, Truvada, Atripla, Eviplera
King's College Hospital NHS Foundation Trust, ViiV Healthcare Ltd
Human Immunodeficiency Virus, People infected with Human Immunodeficiency Virus (HIV), Diseases [C] - Immune System Diseases [C20]
 
 
2016-004646-29: DREAM study Estudio DREAM

Ongoing
4
64
Europe
Triumeq, Genvoya, Tablet, Triumeq, Genvoya
Fundación SEIMC-GESIDA, GILEAD Sciencies S.A.
HIV VIH, HIV VIH, Diseases [C] - Virus Diseases [C02]
 
 
2017-000469-62: Pilot single‐arm clinical trial to evaluate the efficacy, PK interactions and safety of dolutegravir plus 2 NRTIs in HIV‐1‐infected solid organ transplant patients. DGT-SOT Ensayo clínico piloto de un brazo para evaluar la eficacia, las interacciones farmacocinéticas y la seguridad del dolutegravir más 2 inhibidores nucleósidos de la Transcriptasa Inversa (NRTIs en su siglas en inglés) en pacientes trasplantados de órganos sólidos infectados por el VIH-1. DGT-SOT

Ongoing
4
20
Europe
Triumeq 50 mg/600 mg/300 mg comprimidos recubiertos con película dolutegravir/abacavir/lamivudina, Tivicay 50 mg, Truvada comprimidos recubiertos con película., Coated tablet, Tablet, Triumeq®, Dolutegravir 50 mg, 200 mg de emtricitabina y 245 mg de tenofovir disoproxil (equivalente a 300 mg de tenofovir disoproxil fumarato ó 136 mg de tenofovir).
Fundació Clínic per a la Recerca Biomèdica, ViiV Healthcare
HIV-1 infected solid organ transplant patients pacientes trasplantados de órganos sólidos infectados por el VIH-1., HIV-1 infected solid organ transplant patients pacientes trasplantados de órganos sólidos infectados por el VIH-1., Diseases [C] - Virus Diseases [C02]
 
 
2018-001645-14: Study to compare two treatments in patients who have never taken HIV medication randomized in different centers in Spain. (The Symtri study) Estudio para comparar dos tratamientos en pacientes que nunca han tomado medicación para el VIH asignados al azar realizado en diferentes centros de España. (Estudio SYMTRI)

Ongoing
4
316
Europe
Film-coated tablet, Symtuza, Triumeq
Spanish HIV/AIDS Research Networkº, Spanish HIV/AIDS Research Network
HIV infection Infección por VIH, HIV infection Infección por VIH, Diseases [C] - Virus Diseases [C02]
 
 
2018-001158-82: DETOX Study Estudio DETOX

Ongoing
4
110
Europe
Symtuza, Tablet, Symtuza, Triumeq
Fundación SEIMC-GESIDA, JANSSEN CILAG S.A
HIV VIH, HIV VIH, Diseases [C] - Virus Diseases [C02]
 
 
2019-004007-12: BIC CNS Study

Not yet recruiting
4
46
Europe
Biktarvy, Triumeq, Film-coated tablet, Biktarvy, Triumeq
University of Sussex, Gilead Sciences
HIV infection, HIV infection, Diseases [C] - Virus Diseases [C02]
 
 
2019-004620-38: Study to see the changes in body weight and body composition of a darunavir/cobicistat based treatment in HIV-infected people who have gained weight during a dolutegravir-based treatment. Estudio para ver los cambios en el peso y la composición del cuerpo de un tratamiento basado en darunavir/cobicistat en personas con infección por el VIH que han aumentado de peso durante un tratamiento basado en dolutegravir.

Not yet recruiting
4
60
Europe
Triumeq, Rezolsta, Kivexa, Symtuza, Film-coated tablet, Triumeq, Rezolsta, Kivexa, Symtuza
Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA
HIV infection Infección por el VIH, HIV infection Infección por el VIH, Diseases [C] - Immune System Diseases [C20]
 
 
2016-000087-42: Triumeq As an Integrase Single Tablet Regimen in People with HIV who Inject Drugs

Not yet recruiting
4
50
Europe
Triumeq, Film-coated tablet, Triumeq
University College Dublin, ViiV Healthcare
Human Immunodeficiency Virus (HIV) infection, HIV infection, Diseases [C] - Immune System Diseases [C20]
 
 
AVERTAS-1, NCT04904406: Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals

Completed
4
81
Europe
Dolutegravir / Lamivudine Oral Tablet, Dolutegravir/abacavir/lamivudine
Thomas Benfield
Hiv, HIV Infections, HIV Cardiomyopathy, Weight Change, Body, HIV Lipodystrophy, Cardiovascular Diseases
12/23
12/23
2019-004999-19: Changes in weight, body composition and metabolic parameters in HIV infected patients after switched treatment

Not yet recruiting
4
95
Europe
Tablet, Triumeq, Dovato
Department of infectious diseases, Hvidovre Hospital, The Simonsen’s Foundation
Human immunodeficiency viruses (HIV), Human immunodeficiency viruses (HIV), Diseases [C] - Virus Diseases [C02]
 
 
Moso, NCT05393193: POC HIV Testing and Early DTG Use for Infants

Active, not recruiting
4
900
RoW
Point-of-Care Cepheid Xpert HIV-1, DTG/ABC/3TC
Harvard School of Public Health (HSPH), Botswana Harvard AIDS Institute Partnership, Ragon Institute of MGH, MIT and Harvard, Botswana Ministry of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
HIV
05/26
08/26
NCT02131025: A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

Active, not recruiting
3
428
US, Canada
ABC/DTG/3TC FDC, Ongoing cART regimen
ViiV Healthcare, PPD, GlaxoSmithKline
Infection, Human Immunodeficiency Virus
04/15
10/15
FLAIR, NCT02938520 / 2016-001646-25: Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

Active, not recruiting
3
631
Europe, Canada, Japan, US, RoW
Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA), ABC/DTG/3TC STR - Tablet, DTG Tablet
ViiV Healthcare, Janssen Pharmaceuticals, GlaxoSmithKline
HIV Infections
08/18
12/25
2018-004885-32: THE EFFECTS OF SWITCHING FROM DOLUTEGRAVIR/LAMIVUDINE/ABACAVIR (D/L/A) TO BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE (B/F/TAF) IN PATIENTS WITH SUPPRESSED VIRAL LOAD ON NEUROPSYCHIATRIC SIDE EFFECTS AND NEUROCOGNITIVE FUNCTION L’IMPATTO DEL PASSAGGIO DA DOLUTEGRAVIR/LAMIVUDINA/ABACAVIR (D/L/A) A BICTEGRAVIR/EMTRICITABINA/TENOFOVIR ALAFENAMIDE (B/F/TAF) NEI PAZIENTI IN TERAPIA ANTIRETROVIRALE CON HIVRNA SOPPRESSO SUGLI EVENTI AVVERSI NEUROPSICHIATRICI E SULLE FUNZIONI NEUROCOGNITIVE

Not yet recruiting
3
100
Europe
bictegravir/emtricitabina/tenofovir alafenamide, TRIUMEQ, [GS-9883-01], [dolutegravir/abacavir/lamivudina], Tablet, BIKTARVY, TRIUMEQ
AZIENDA OSPEDALIERA UNIVERSITARIA SENESE, Gilead Sciences
HIV-1 infection Infezione da HIV-1, Human immunodeficiency virus type 1 (HIV-1) infection Infezione da virus dell'immunodeficienza umana acquisita 1 (HIV-1), Diseases [C] - Virus Diseases [C02]
 
 
2020-005069-15: LIGHTHOUSE 2

Not yet recruiting
3
390
Europe
Triumeq, Capsule, Triumeq
Stichting TRICALS Foundation, ALS Stichting Nederland., Fight MND, Ulla-Carin Lindquist Foundation, Luzon Foundation, Research Motor Neurone
Amyotrophic Lateral Sclerosis (ALS), ALS/ Motor Neuron Disease (MND), Diseases [C] - Nervous System Diseases [C10]
 
 
2022-001437-36: ITACO study and the Analytical Antiretroviral Treatment Interruption study (ITACO-ATI) Studio ITACO e studio sull'interruzione del Trattamento Antiretrovirale (ITACO-ATI)

Not yet recruiting
3
61
Europe
ODEFSEY, REZOLSTA, BIKTARVY, Triumeq, Edurant, Tivicay, Descovy, Symtuza, Dovato, Epivir, [na], Film-coated tablet, ODEFSEY - 200 MG/25 MG/25 MG- COMPRESSA RIVESTITA- USO ORALE- FLACONE (HDPE) 30 COMPRESSE, REZOLSTA - 800 MG/ 150 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE-FLACONE (HDPE)- 30 COMPRESSE, Biktarvy, TRIUMEQ - 50MG/600MG/300 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE HDPE - 1 FLACONE 30 COMPRESSE, EDURANT - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) 30 COMPRESSE, TIVICAY - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE, DESCOVY - 200 MG/10 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE, Symtuza, DOVATO - 50 MG / 300 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE, EPIVIR - 300 MG 1 FLACONE 30 COMPRESSE RIVESTITE CON FILM USO ORALE
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA, NIH (Johns Hopkins University)
perinatally HIV infection Infezione da HIV perinatale, perinatally HIV infection Infezione da HIV perinatale, Diseases [C] - Immune System Diseases [C20]
 
 
2020-001426-57: A study to compare whether giving two rather than three anti-HIV medicines daily to children and young people, aged between 2 and 15 years is assafe and effective in controlling their HIV infection Ensayo para comparar si la administración de dos en vez de tres fármacos anti-VIH diariamente en niños y pacientes jóvenes entre 2 y 15 años es tan segura y efectiva en el control de su infección por VIH.

Not yet recruiting
3
370
Europe
DTG/3TC DT, Dovato, Tivicay PD, Tivicay, Triumeq, Kivexa, Ziagen, Epivir, Combivir, Retrovir, Truvada, Descovy, Dolutegravir, Dispersible tablet, Film-coated tablet, Capsule, hard, Dovato, TIVICAY PD, TIVICAY, Triumeq, Kivexa, Ziagen, Epivir, Combivir, Retrovir, Truvada, Descovy
Fondazione Penta Onlus, ViiV Healthcare UK Limited
HIV Infection Infección por VIH, HIV Infection Infección por VIH, Diseases [C] - Virus Diseases [C02]
 
 
NCT03016533: Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019

Completed
3
101
US, RoW
Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets, ABC/DTG/3TC film-coated dispersible tablets
ViiV Healthcare
HIV Infections
12/24
12/24
Lighthouse III, NCT06658977: RolloverTreatment With Triumeq for People With ALS Following the Lighthouse II Trial

Enrolling by invitation
3
70
RoW
Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)
Macquarie University, Australia
Amyotrophic Lateral Sclerosis, ALS
12/26
12/26
LIGHTHOUSE II, NCT05193994: Triumeq in Amyotrophic Lateral Sclerosis

Active, not recruiting
3
390
Europe, RoW
Dolutegravir, Abacavir and Lamivudine, Triumeq, Placebo
Macquarie University, Australia, King's College London, Stichting TRICALS Foundation
Amyotrophic Lateral Sclerosis
06/25
06/25
Tivicay (dolutegravir) / ViiV Healthcare
2013-003704-39: CV risk in HIV patients switching from a boosted PI to DTG

Ongoing
4
112
Europe
Dolutegravir, Darunavir, Atazanavir, Kaletra, Ritonavir, Fosamprenavir, INVIRASE, Tivicay, Prezista, Reyataz, Kaletra, Norvir, Telzir, Invirase, Tivicay, Prezista, Reyataz, Kaletra, Norvir, Telzir, Invirase
St Stephen\'s AIDS Trust, NEAT-ID, Viiv Healthcare Ltd
HIV infection
 
 
InMIND, NCT02406196: Integrase and Maraviroc Intensification for Neurocognitive Dysfunction

Not yet recruiting
4
186
NA
Placebo for MVC, Maraviroc, MVC, Placebo for DTG, Dolutegravir, DTG
AIDS Clinical Trials Group, National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
06/17
06/18
2019-000199-41: A study to evaluate the impact of the change of antiretroviral treatment from dual therapy to triple therapy on inflammation in HIV+ patients. Estudio para evaluar el impacto del cambio de tratamiento antirretroviral de terapia dual a terapia triple sobre la inflamación en pacientes VIH +

Not yet recruiting
4
234
Europe
Bictarvy, Tivicay, Epivir, Tablet, Bictarvy, Tivicay, Epivir
Fundación SEIMC-GESIDA, Gilead Sciences, S.L
HIV VIH, HIV VIH, Diseases [C] - Virus Diseases [C02]
 
 
2019-002733-10: Exploratory, open-label, randomized clinical trial to assess the efficacy of first-line dual vs. triple antiretroviral therapy (art) in hiv-1 reservoir and in peripheral compartments in hiv-infected patients. Ensayo clínico abierto, aleatorizado para evaluar el efecto del tratamiento antirretroviral inicial doble vs.triple en el reservorio del VIH-1 y en tejidos periféricos en pacientes infectados por el VIH-1.

Ongoing
4
44
Europe
Coated tablet, Tivicay, Descovy, Lamivudine
FUNDACIÓ LLUITA CONTRA LA SIDA, Viiv Healthcare
HIV infection Infección por VIH, HIV infection Infección por VIH, Diseases [C] - Virus Diseases [C02]
 
 
ChiCTR1900027640: A real world study for a simplified regimen of dolutegravir combined with lamivudine in the treatment of newly infected HIV patients

Not yet recruiting
4
30
 
DTG 50mg +3TC 300mg once a day
The Fifth Affiliated Hosipital Of Sun Yat-sen University; The Fifth Affiliated Hosipital Of Sun Yat-sen University, Hospital funding and self-finacing
HIV/AIDS
 
 
ChiCTR1900027321: Prospective, non-inferior, randomized controlled trial of post-exposure prevention regimens for HIV

Not yet recruiting
4
276
 
Once a day with Elvitegravir150mg/Cobicistat 150mg/Emtricitabine200mg/Tenofovir AlafenamideFumarate 10mg Tablets ;Lamiwudine300mg/Tenofovir Disoproxl1 Pumarnte Tablets 300mg once a day plus Dolutegravir Sodium Tablets 50mg once a day
the Fifth Affiliated Hospital of Sun Yat-sen University; The fifth affiliated hospital of sun yat-sen university, self-finacing
AIDS
 
 
NCT02800655: Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy

Active, not recruiting
4
100
US
Digital Health Feedback System
University of California, San Diego, National Institute of Mental Health (NIMH), Gilead Sciences, ViiV Healthcare, GlaxoSmithKline, Proteus Digital Health, Inc.
HIV
12/21
12/23
NCT04340388: Contribution of Dolutegravir to Obesity and Cardiovascular Disease

Completed
4
10
US
Dolutegravir 50 MG, Tenofovir alafenamide, Tenofovir disoproxil fumarate, Abacavir, Lamivudine, Darunavir, Cobicistat, Rilpivirine, Combivir, Zidovudine, Antiretroviral/Anti HIV, Antiretroviral Combinations
Augusta University
HIV-1-infection, Antiviral Drug Adverse Reaction, Vascular Diseases, Cardiovascular Abnormalities, Abnormality of Adipose Tissue, Body Weight Changes, Body Fat Disorder, HIV-Associated Lipodystrophy Syndrome
06/22
02/23
2018-003458-26: Evaluating inflammatory and immunological changes of HIV-positive patients switching to DTG dual regimen compared to those switching to a triple drugs regimen (B/F/TAF). Valutazione dei cambiamenti a livello infiammatorio e immunologico nei pazienti con infezione da HIV che passano a un doppio regime terapeutico contenente DTG rispetto a quelli che passano a un triplo regime (B/F/TAF).

Not yet recruiting
4
66
Europe
lamivudina, dolutegravir, bictegravir/emtricitabina/tenofovir alafenamide fumarato, [3TC], [DTG], [B/F/TAF], Film-coated tablet, Biktarvy
AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA, Gilead Sciences Inc.
HIV infection infezione da HIV, HIV infection infezione da HIV, Diseases [C] - Virus Diseases [C02]
 
 
ORCHID, NCT04746547: Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB

Recruiting
4
20
RoW
Dolutegravir 50 MG, Dolutegravir 10 MG
University of KwaZulu, Centre for the AIDS Programme of Research in South Africa
Tuberculosis, Hiv
07/25
07/25
ChiCTR2100045021: Drug concentration monitoring of albuvirtide/dolutegravir in the treatment of HIV-1 patients with end-stage renal disease

Recruiting
4
10
 
Albuvirtide and dolutegravir
Chongqing Public Health Medical Center; Chongqing Public Health Medical Center, Chongqing Red-ribbon HIV/AIDS Care Center
HIV
 
 
ChiCTR2300072308: Study on the efficacy and safety of Dolutegravir combined with Lamivudine in the treatment of HIV infections

Completed
4
72
 
None ;None
Chest Hospital of Guangxi Zhuang Autonomous Region (Longtan Hospital of Guangxi Zhuang Autonomous Region); Chest Hospital of Guangxi Zhuang Autonomous Region (Longtan Hospital of Guangxi Zhuang Autonomous Region), Scientific and technological funds provided by Guangxi Liuzhou Science and Technology Bureau, self-owned funds of Chest Hospital of Guangxi Zhuang Autonomous Region (Longtan Hospital)
Acquired immune deficiency syndrome
 
 
CODA, NCT04910711: Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV

Active, not recruiting
4
140
RoW
Dolutegravir, Levonorgestrel implant, Depo medroxyprogesterone acetate injection
Botswana Harvard AIDS Institute Partnership, University of Liverpool
Human Immunodeficiency Virus, Contraception, ART
08/23
10/24
DoRIS, NCT04166474: Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

Completed
4
36
RoW
Dolutegravir
Helen Reynolds, Infectious Disease Institute, Kampala, Uganda, Desmond Tutu HIV Centre
Hiv, Tuberculosis
02/24
02/24
DoraDO, NCT05630638: Doravirine Dose Optimisation in Pregnancy

Recruiting
4
76
RoW
Doravirine, Delstrigo, Dolutegravir, TLD
University of Liverpool, Liverpool School of Tropical Medicine, Desmond Tutu Health Foundation
HIV
11/25
02/26
OPTIMAL, NCT04708496: Optimizing Malaria Treatment for HIV-Malaria Co-infected Individuals

Recruiting
4
888
RoW
Artemether-lumefantrine, Efavirenz, Dolutegravir
Makerere University
HIV Coinfection, Malaria
01/24
03/24
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Isentress (raltegravir) / Merck (MSD)
ACTRN12609000881235: A randomised open-label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2-3 nucleoside reverse transcriptase inhibitors (NRTI) backbone versus ritonavir boosted lopinavir and raltegravir in participants virologically failing first-line non-nucleoside reverse transcriptase inhibitors (NNRTI)/2 NRTI therapy (the SECOND-LINE study). This study is for Human Immunodeficiency Virus (HIV) infection.

Active, not recruiting
4
550
 
University of New South Wales/Kirby Institute, University of New South Wales/Kirby Institute, Abbott, Merck Sharpe & Dohme, amfAR
Human Immunodeficiency Virus (HIV) -1 infection
 
 
2011-005270-35: Study of the effect of pregnancy on the concentrations of antiretroviral drugs in the blood of women with HIV infection Studio dell'effetto della gravidanza sulle concentrazioni dei farmaci antiretrovirali nel sangue di donne con infezione da HIV

Ongoing
4
120
Europe
Tablet, Capsule, soft, Capsule, hard, Film-coated tablet, VIRAMUNE*60CPR 200MG, COMBIVIR*FL 60CPR RIV, KALETRA*120CPR RIV 200MG+50MG, REYATAZ*60CPS 150MG, TRUVADA*30CPR RIV 200MG/245MG, PREZISTA*60CPR RIV 600MG, ISENTRESS*FL 60CPR RIV 400MG, NORVIR*FL 84CPS MOLLI 100MG
ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI, Istituto Superiore di Sanita'
HIV-1 infection Infezione da HIV-1, HIV infection Infezione da HIV, Diseases [C] - Virus Diseases [C02]
 
 
2014-003710-84: The CNS Integrase Inhibitor Study

Ongoing
4
22
Europe
Tivicay, Isentress, Truvada, Film-coated tablet, Tivicay, Isentress, Truvada
Imperial College London
Human Immunodificiency Virus, HIV, Diseases [C] - Virus Diseases [C02]
 
 
2015-000274-35: clinical trial to assess the safety, tolerability and efficacy of two dolutegravir-based simplification strategies in HIV-infected patients with prolonged virological suppression. ENSAYO CLÍNICO PARA EVALUAR LA SEGURIDAD, TOLERABILIDAD Y EFICACIA DE DOS ESTRATEGIAS DE SIMPLIFICACIÓN BASADAS EN DOLUTEGRAVIR EN PACIENTES INFECTADOS POR VIH CON SUPRESIÓN VIROLÓGICA SOSTENIDA.

Ongoing
4
450
Europe
Lamivudine, Efavirenz, nevirapine, J05AX12, Coated tablet, Capsule, hard, Tablet, Prolonged-release tablet, Tivicay, Stribild, TRUVADA, KIVEXA, ZIAGEN, VIREAD, EMTRIVA, ATRIPLA, EVIPLERA, ISENTRESS, RAYATAZ, PREZISTA, KALETRA, NORVIR, INTELENCE, EDURANT, TRIUMEQ
Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA
Infection with human immunodeficiency virus (HIV). Infección por el virus de la inmunodeficiencia humana (VIH)., HIV infection Infección por VIH, Diseases [C] - Virus Diseases [C02]
 
 
2008-001611-38: Estudio piloto prospectivo de la farmacocinética y farmacodinamia de la interaciión entre tipranavir/ritonavir y raltegravir en pacientes infectados por el VIH-1

Ongoing
4
10
Europe
Isentress, Aptivus, Norvir, raltegravir, tipranavir, ritonavir, Isentress, Aptivus, Norvir, Isentress, Aptivus, Norvir
Jose M Gatell - Hospital Clinic de Barcelona
Pacientes con infección crónica por VIH-1
 
 
2009-013679-23: étude cas-témoins comparant l\'efficacité d’une combinaison thérapeutique contenant l\'inhibiteur de l\'intégrase raltégravir (400 mg x 2) ou une combinaison thérapeutique ne contenant pas le raltégravir sur la diminution de l\'ADN proviral chez des sujets prétraités présentant une infection par le VIH-1 avec une charge virale détectable

Ongoing
4
60
Europe
Raltegravir, J05AX08, Raltegravir, Raltegravir
STOP SIDA
Patients âgés de plus de 18 ans, infectés par le VIH et traités par Raltégravir.
 
 
2014-004578-40: SSAT 066 Renal Integrase Study

Not yet recruiting
4
60
Europe
Tivicay 50 mg film - coated tablets, Isentress 400 mg Film-coated Tablets, Truvada 200 mg/245 mg film-coated tablets, Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets, Film-coated tablet, Tivicay 50 mg film-coated tablets, Isentress 400 mg Film-coated Tablets, Truvada 200 mg/245 mg film-coated tablets, Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets
St Stephen's AIDS Trust, Merck, Sharp & Dohme Limited
HIV
 
 
2016-000437-43: The time to protection and adherence requirements of Raltegravir with or without lamivudine in protection from HIV infection

Not yet recruiting
4
36
Europe
Raltegravir, Lamivudine, Tablet, Film-coated tablet, Raltegravir, Lamivudine
Guy's and St Thomas NHS Foundation Trust, Merck Sharp & Dhome Ltd
HIV, HIV, Diseases [C] - Virus Diseases [C02]
 
 
2017-004750-42: EFFICACY AND SAFETY OF A SIMPLIFICATION TREATMENT BASED ON DOLUTEGRAVIR AND DARUNAVIR / COBICISTAT VS USUAL TREATMENT IN SUPPRESSED HIV-1-INFECTED PATIENTS WITH MULTIDRUG RESISTANCE. Eficacia y seguridad de Dolutegravir más Darunavir/cobicistat como tratamiento de simplificación frente al tratamiento habitual en pacientes infectados por el VIH-1 virológicamente suprimidos y con resistencia a múltiples fármacos.

Ongoing
4
100
Europe
lamivudine, Efavirenz, Nevirapine, Film-coated tablet, Coated tablet, Capsule, hard, Tablet, Rezolsta, Tivicay, Ziagen, EMTRIVA, VIREAD, kivexa, Truvada, Intelence, Edurant, Atripla, Eviplera, Reyataz, Prezista, Kaletra, Norvir, Evotaz, Isentress, Stribild, Triumeq, Genvoya, Celsentri, Descovy
FUNDACIÓ LLUITA CONTRA LA SIDA, ViiV Healthcare
HIV-1 VIH-1, HIV infection Infección por VIH, Diseases [C] - Virus Diseases [C02]
 
 
2017-003470-14: Raltegravir One Thousand two hundred vs Darunavir-cb in Immnunosupressed Patients: ROTDIP Study Raltegravir 1200 versus Darunavir-cb en pacientes inmunodeprimidos: estudio ROTDIP

Not yet recruiting
4
75
Europe
Film-coated tablet, , ISENTRESS
FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud, APES Costa del Sol (Agencia Pública Empresarial Sanitaria Costa del Sol), MSD Merck Sharp & Dohme, MSD MErck Sharp & Dohme
Human Immunodeficiency Virus (HIV) infection Infección por el Virus de Inmunodeficiencia Humana (VIH), Human Immunodeficiency Virus (HIV) infection Infección por el Virus de Inmunodeficiencia Humana (VIH)., Diseases [C] - Virus Diseases [C02]
 
 
NCT04258475: The Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir.

Recruiting
4
12
Canada
Raltegravir standard dosage of 1200 mg (two 600 mg tablets) orally once daily., RAL, Isentress®, Calcium carbonate antacid tablet, TUMS® Ultra Strength (US) 500 mg
Ottawa Hospital Research Institute
Calcium Supplementation in HIV Patients Using Raltegravir
06/24
01/25
PANNA-B PK, NCT05648201: Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers

Recruiting
4
36
Europe
Doravirine 100Mg Tab, pifeltro, Raltegravir 600Mg Tab, issentres, Biktarvy 50/200/25 Tab, biktarvy
Radboud University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development, Merck Sharp & Dohme LLC
Hiv
11/24
12/24
ACTRN12609000575235: Antiretroviral therapy intensification with raltegravir and/or hyper-immune bovine colostrum in Human Immunodeficiency Virus-1 (HIV-1) infected patients with suboptimal immunological response

Active, not recruiting
3/4
72
 
University of New South Wales (UNSW), National Centre in HIV Epidemiology and Clinical Research University of New South Wales (UNSW)
Human Immunodeficiency Virus (HIV)Infection
 
 
NCT00717964: Study of Raltegravir Versus Nucleotide Reverse Transcriptase Inhibitors (NRTIs) as a Backbone in HIV-Infected Subjects Switched From a Stable Boosted Protease Inhibitor (PI) Regimen

Active, not recruiting
3
34
US
Raltegravir, Isentress, current antiretroviral regimen
St. Joseph's Hospital, Florida
HIV Infections
07/11
10/11
2007-000783-25: A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus KALETRA™ in HIV-Infected Patients Switched from a Stable KALETRA™-Based Regimen - Study A

 
3
32
Europe
Kaletra (Lopinavir Ritonavir), MK-0518, KALETRA, KALETRA
Merck Sharp & Dohme de España, S.A., Merck & Co., Inc., Merck Sharp & Dohme Limited, MERCK SHARP DOHME, Merck Sharp & Dohme, Lda.
HIV Infection
 
12/08
2008-002733-70: A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK-0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients

 
3
65
Europe
ISENTRESS, TRUVADA, MK-0518, ISENTRESS, TRUVADA, ISENTRESS, TRUVADA
Merck & Co., Inc., Merck & Co Inc.,, Merck & Co. Inc., Laboratoires Merck Sharp & Dhome-Chibret, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., MERCK & CO., INC., MSD BV
HIV infection
 
05/11
2010-018878-21: A phase III, open-label, single centre, single-arm, pilot study to assess the feasibility of switching, individuals receiving efavirenz with continuing Central Nervous System (CNS) toxicity, to raltegravir

Ongoing
3
40
Europe
Isentress, Truvada (tenofovir disoproxil/emtricitabine), Isentress, Truvada, Isentress, Truvada
St Stephen\'s AIDS Trust
HIV
 
 
2019-001961-34: ANRS 173 ALTAR (ALlégement du Traitement AntiRétroviral) ANRS 173 ALTAR (ALlégement du Traitement AntiRétroviral)

Not yet recruiting
3
360
Europe
Film-coated tablet, , VIREAD or Tenofovir disoproxil fumarate (generic drug), STRIBILD 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir), BIKTARVY bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide., ISENTRESS, TIVICAY, DESCOVY 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide, GENVOYA 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide, EPIVIR or Lamivudine (generic drugs), TRUVADA or Emtricitabine and tenofovir disoproxil fumarate (Generic drug)
INSERM ANRS, ANRS
Hiv Infection Infection par le VIH, Hiv Infection Infection par le VIH, Diseases [C] - Virus Diseases [C02]
 
 
2008-004970-41: Phase II open-label randomized multicenter trial to compare the efficacy and safety of two different doses of raltegravir and efavirenz, all in combination with tenofovir and lamivudine, in naive HIV-1-infected patients receiving rifampin for active tuberculosis.

Ongoing
2
15
Europe
Sustiva, Viread, Epivir, MK-0518, BMS-561525, raltegravir, Sustiva, Viread, Epivir, Isentress, Sustiva, Viread, Epivir, Isentress
Agence nationale de recherches sur le sida et les hépatites virales. ANRS.
HIV-1 Infection and tuberculosis
 
 
2009-016480-11: “No Nuc, No Boost” : A phase 2 pilot study of simplification by Maraviroc-Raltegravir following 6 months of treatment with Maraviroc-Raltegravir-Tenofovir-Emtricitabine in naive patients infected by CCR5 HIV-1

Ongoing
2
40
Europe
Raltegravir, Maraviroc, Tenofovir/Emtricitabine, ISENTRESS, CELSENTRI, TRUVADA, ISENTRESS, CELSENTRI, TRUVADA
P Pierre Dellamonica
HIV naïve patients, CCR5 tropism, with CD4 > 200/mm3 and HIV RNA < 100 000 copy/ml.
 
 
2009-014406-34: International, multicenter, randomized, non-comparative controlled study of therapeutic intensification plus immunomodulation in HIV patients with long-term viral suppression

Ongoing
2
12
Europe
GLYCOSYLATED RECOMBINANT HUMAN INTERLEUKIN-7, MARAVIROC, RALTEGRAVIR, CYT107, SELZENTRY, CELSENTRI, ISENTRESS, SELZENTRY, CELSENTRI, ISENTRESS
ORVACS, KEYRUS BIOPHARMA, , Bettencourt-Schueller Foundation
HIV-1 Infection
 
 
RIVER, NCT02336074 / 2014-001425-32: Research In Viral Eradication of HIV Reservoirs

Completed
2
60
Europe
Combination Antiretroviral Therapy (cART), Raltegravir, Isentress, Vorinostat, ChAdV63.HIVconsv (ChAd), MVA.HIVconsv (MVA)
Imperial College London, Medical Research Council, University of Oxford, University of Cambridge, Chelsea and Westminster NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Central and North West London NHS Foundation Trust
HIV
11/17
03/23
2019-004195-19: A randomized comparative phase II trial evaluating the capacity of the dual combination doravirine/raltegravir to maintain virological success in HIV-1 infected patients with an HIV-RNA plasma viremia below 50 copies/mL under a current antiretroviral regimen

Not yet recruiting
2
150
Europe
Isentress, Pifeltro, J05AX08, J05AR24, Tablet, ISENTRESS, Pifeltro
Centre de Recherche et d’Etudes sur la Pathologie Tropicale et le Sida (CREPATS), Centre de Recherche et d’Etudes sur la Pathologie Tropical et le Sida (CREPATS), CREPATS, Centre de Recherche et d’Etudes sur la Pathologie Tropical et le Sida (CREPATS)
HIV disease, HIV disease, Diseases [C] - Virus Diseases [C02]
 
 
NCT03954327: Combination Antiretroviral Therapy (cART) for PBC

Completed
2
37
Canada
Emtricitabine (FTC)/Tenofovir Disoproxil (TDF), Truvada, Raltegravir, Isentress, Placebo Oral Capsule [CEBOCAP], placebo
University of Alberta, Merck Sharp & Dohme LLC
Primary Biliary Cholangitis
10/22
01/24
DORAL, NCT04513626: HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine/Raltegravir Open Label

Recruiting
2
150
Europe
DORAVIRINE 100 MG [Pifeltro], Raltegravir 600 Mg x 2 [Isentress]
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
HIV Infections
10/25
10/25
NCT02140255: Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Recruiting
1/2
1120
US, RoW
Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Nevirapine (NVP), Lopinavir/Ritonavir (LPV/r), Raltegravir (RAL), VRC01, DTG, VRC07-523LS
National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
HIV Infection
01/28
12/31
NCT03174977: Pharmacokinetics Distribution of Raltegravir by PET/MR

Recruiting
1
10
US
18F-Raltegravir
University of California, San Francisco, Merck Sharp & Dohme LLC
HIV-1-infection
11/24
01/25
POPARV, NCT03194165: Population Pharmacokinetics of Antiretroviral in Children

Completed
N/A
65
Europe
Dolutegravir, Raltegravir, Rilpivirine, Nevirapine, Atazanavir, Darunavir, Ritonavir
Assistance Publique - Hôpitaux de Paris
Minor Patient Treated by One or More Antiretroviral and for Which a Blood Test Has Been Performed
06/22
06/22
RalAge2, NCT03579485: An Observational Retrospective Database Analysis to Evaluate Raltegravir Based-regimens, Including NUC-sparing Regimens, in Aged HIV Patients.(RalAge)

Recruiting
N/A
90
Europe
Azienda Policlinico Umberto I
Hiv
12/23
12/24
EPPICC, NCT05751031: Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration

Recruiting
N/A
1200
Europe, RoW
Raltegravir
Fondazione Penta UK, UCL Great Ormond Street Institute of Child Health
HIV Infections
02/24
02/24
NCT00537966: Characterization of Acute and Recent HIV-1 Infections in Zurich.

Recruiting
N/A
800
Europe
Dolutegravir, Tivicay, Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamid Fumarate, Genvoya, Raltegravir, isentress, Darunavir, Prezista, Ritonavir, Norvir, Rilpivirine, Edurant, Lamivudine, 3TC, tenofovir, Viread, Emtricitabine, Emtriva, Abacavir, Ziagen
University of Zurich
HIV Infections
12/28
12/28
ACTRN12608000177358: An open label study to examine the characteristics of Human Immunodeficiency Virus (HIV) decay following introduction of combination antiretroviral therapy including raltegravir during primary and chronic HIV infection

Active, not recruiting
N/A
16
 
National Centre in HIV Epidemiology and Clinical Research, National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales (UNSW), Merck, Sharp and Dohme
Primary HIV (acute or early), Chronic HIV infection
 
 
Vocabria (cabotegravir oral) / ViiV Healthcare
PILLAR, NCT05374525: A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States

Completed
4
201
US
APRETUDE, Cabotegravir OLI
ViiV Healthcare
HIV Infections
08/24
08/24
EBONI, NCT05514509: A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

Active, not recruiting
4
66
US
APRETUDE, Cabotegravir tablet
ViiV Healthcare
HIV Infections
09/25
09/25
Tshireletso, NCT05986084: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana

Recruiting
4
500
US, RoW
Cabotegravir Injection [Apretude]
Beth Israel Deaconess Medical Center, Botswana Harvard AIDS Institute Partnership, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), ViiV Healthcare
Pre-Exposure Prophylaxis (PrEP), Breast Feeding
08/27
08/27
ATLAS-2M, NCT03299049 / 2017-002946-62: Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

Active, not recruiting
3
1049
Europe, Canada, US, RoW
Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir Injectable Suspension, Rilpivirine Injectable Suspension
ViiV Healthcare, Janssen Research and Development
HIV Infections
06/19
12/25
HPTN 084, NCT03164564: Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

Active, not recruiting
3
3224
RoW
Oral CAB, Cabotegravir, Oral TDF/FTC, Tenofovir disoproxil fumarate/emtricitabine, Truvada, Placebo for oral CAB, Placebo for oral TDF/FTC, CAB LA, Cabotegravir long-acting injectable, Placebo for CAB LA
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
11/20
11/24
SOLAR, NCT04542070 / 2020-002623-11: A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

Completed
3
687
Europe, Canada, Japan, US, RoW
Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA), Rilpivirine Tablets, Rilpivirine Injectable Suspension (RPV LA), BIKTARVY Tablets (BIK)
ViiV Healthcare, Janssen, LP
HIV Infections
07/22
04/23
NCT05896761: A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants

Completed
3
118
Europe, Canada, US, RoW
Cabotegravir Injectable Suspension, Rilpivirine Injectable Suspension
ViiV Healthcare, Janssen Research and Development
Human Immunodeficiency Virus Type 1 (HIV-1)
08/22
08/22
NCT05896748: Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study

Completed
3
94
Europe, Canada, Japan, US, RoW
Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA)
ViiV Healthcare, Janssen Pharmaceuticals, GlaxoSmithKline
Human Immunodeficiency Virus Type 1 (HIV-1)
09/23
09/23
LAPIS, NCT06250504: Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT

Recruiting
3
2000
RoW
APRETUDE (cabotegravir) 600 mg\3 mL, DAPIRING (Dapivirine) 25mg Vaginal Ring, tenofovir disoproxil and emtricitabine, Tenofovir Disoproxil, Lamuvidine and Dolutegravir
Africa Health Research Institute
HIV Infections
07/25
03/26
CABOPrEP, NCT06273943: Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.

Not yet recruiting
3
322
Europe
Cabotegravir Tablets, for oral use., VOCABRIA, Cabotegravir Extended-Release Injectable Suspension, for intramuscular use., APRETUDE, Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use, TRUVADA, Rectal Biopsies
ANRS, Emerging Infectious Diseases
Prevention
10/25
10/26
MOBILEMEN, NCT06133686: Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa

Not yet recruiting
3
400
NA
Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA), Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC)
MRC/UVRI and LSHTM Uganda Research Unit, King's College London, London School of Hygiene and Tropical Medicine, Africa Health Research Institute, Wits Health Consortium (Pty) Ltd, University College, London, Ministry of Health, Uganda, Desmond Tutu HIV Foundation, Assistance Publique - Hôpitaux de Paris
HIV
12/25
04/27
NCT03635788: The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE

Active, not recruiting
3
456
US
Standard of Care (SOC) Oral ART, Oral RPV, Rilpivirine, Oral CAB, Cabotegravir, GSK1265744, RPV-LA Loading Dose, Rilpivirine Long-Acting Injectable, CAB-LA Loading Dose, Cabotegravir Long-Acting Injectable, RPV-LA Maintenance Dose, CAB-LA Maintenance Dose
National Institute of Allergy and Infectious Diseases (NIAID), ViiV Healthcare
HIV Infections
02/24
08/26
VOLITION, NCT05917509: A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

Active, not recruiting
3
171
Europe, Canada, US, RoW
DTG/3TC, Dovato, Cabotegravir (CAB) LA, Vocabria, Rilpivirine (RPV) LA, Rekambys
ViiV Healthcare, GlaxoSmithKline, PPD DEVELOPMENT, LP
HIV Infections
10/25
10/26
LATTE-2, NCT02120352 / 2013-000783-29: A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects

Completed
2
309
Europe, Canada, US
CAB Oral Tablets, CAB LA, ABC/3TC Oral tablets, RPV Oral Tablets, HAART, RPV
ViiV Healthcare, Janssen Pharmaceuticals, GlaxoSmithKline
Infection, Human Immunodeficiency Virus, HIV Infections
08/15
04/23
NCT04824131: Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females

Completed
2
55
RoW
Oral cabotegravir (CAB), CAB LA, Oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)
National Institute of Allergy and Infectious Diseases (NIAID), ViiV Healthcare, Bill and Melinda Gates Foundation
HIV Infections
01/23
01/23
NCT04692077: Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males

Completed
2
9
US
Cabotegravir (CAB) tablet, CAB LA, Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
07/23
07/23
EMBRACE, NCT05996471: A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

Active, not recruiting
2
135
US
VH3810109, Cabotegravir, Standard of care (SOC), rHuPH20
ViiV Healthcare
HIV Infections
11/24
01/29
NCT01215006: A Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects

Active, not recruiting
1
48
US
GSK1265744 injectable suspension, Placebo to match injectable suspension
GlaxoSmithKline, ViiV Healthcare
Infections, Human Immunodeficiency Virus and Herpesviridae, HIV Infection
05/12
05/12
NCT04484337: Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants

Completed
1
138
US, RoW
Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL, Cabotegravir 200 mg/mL, Topical non-steroidal anti-inflammatory drug, Topical steroid, Placebo creams/gels, Recombinant human hyaluronidase PH20 (rHuPH20)
ViiV Healthcare
HIV Infections
05/23
05/23
NCT05776108: A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation

Completed
1
24
US
Cabotegravir IR Formulation (reference), Cabotegravir DT Formulation (test 1), Cabotegravir DT Formulation (test 2)
ViiV Healthcare
HIV Infections
06/23
06/23
NCT05418868: A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

Recruiting
1
180
US
Cabotegravir 200 mg/mL, Cabotegravir >=400 mg/mL, Cabotegravir Formulation I, rHuPH20, RPV
ViiV Healthcare, GlaxoSmithKline, Janssen Sciences Ireland Unlimited Company
HIV Infections
07/26
11/27
NCT05112939: A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants

Completed
1
126
Europe, US
RPV LA, TMC278, CAB LA, GSK1265744
Janssen Research & Development, LLC
Healthy
05/24
05/24
NCT06033547: A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants

Active, not recruiting
1
56
US
Cabotegravir Formulation F, Cabotegravir Formulation G
ViiV Healthcare
HIV Infections
06/25
06/25
NCT03462810: GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV

Available
N/A
NA
cabotegravir, CAB, cabotegravir, CAB
ViiV Healthcare
Infection, Human Immunodeficiency Virus
 
 
NCT06405464: Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures

Recruiting
N/A
600
Europe
VOCABRIA 30Mg Tablet, Cabotegravir Tablets, EDURANT 25Mg Tablet, Rilpivirine Tablets, Cabotegravir Injectable Suspension, Vocabria, Rilpivirine Injectable Suspension, Rekambys, Intact proviral DNA assay, Full-length sequencing
University of Zurich, Swiss HIV Cohort Study
HIV Infections
12/25
06/26
NCT06643897: Identification of Barriers and Facilitators of Implementation of the Out-of-Hospital Administration of the Long- Acting Combination Cabotegravir+Rilpivirina.

Completed
N/A
13
Europe
Qualitative Interview
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
HIV-1-infection
10/24
10/24
SCohoLART, NCT05663580: Cohort Study of HIV-positive People, Treated with Long Acting Antiretroviral Therapy

Recruiting
N/A
1500
Europe
Cabotegravir 600mg/3mL, Rilpivirine 900mg/3mL
Castagna Antonella
HIV Infections
07/24
07/27
CHEERS, NCT06565013: Chemsex Health Evaluation With Extended Release System for HIV Treatment

Not yet recruiting
N/A
50
Canada
Cabenuva 600/900, Self administered questionnaires, Semi-directed interview
Clinique Médicale L'Actuel, ViiV Healthcare
HIV
02/26
02/26
NCT06704204: Long-acting Injectable Antiretroviral Treatment to Improve HIV Treatment Among Justice-involved Persons Being Released to the Community

Not yet recruiting
N/A
20
NA
The first FDA-approved LAI ART regimen includes an integrase inhibitor, cabotegravir (CAB), and a non-nucleoside reverse transcriptase inhibitor, rilpivirine (RPV) combined 4 wks
The Miriam Hospital, National Institute on Drug Abuse (NIDA)
HIV
07/25
07/25
ChiCTR2400089435: Evaluation of 28-week Antiretroviral Treatment with Albuvirtide and Cabotegravir in HIV Patients with Stable Virologic Suppression: Efficacy, Pharmacokinetics, and Safety

Not yet recruiting
N/A
10
 
Albuvirtide combined with Categlusevir
Guangzhou Eighth Peoples Hospital Guangzhou Medical University; Guangzhou Eighth Peoples Hospital Guangzhou Medical University, self-financing
HIV/AIDS
 
 
NCT04518228: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Active, not recruiting
N/A
205
US, RoW
Bictegravir (BIC), Tenofovir alafenamide (TAF), Cabotegravir (CAB), Dolutegravir (DTG), Atazanavir/ritonavir (ATV/r), Darunavir/ritonavir (DRV/r), Lopinavir/ritonavir (LPV/r), Cobicistat, Ritonavir, First-Line TB Treatment, Second-Line TB Treatment, Doravirine (DOR)
National Institute of Allergy and Infectious Diseases (NIAID), International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), Gilead Sciences, ViiV Healthcare, Merck Sharp & Dohme LLC
HIV Infections, Tuberculosis
03/26
03/26
Triumeq (dolutegravir/abacavir/lamivudine) / ViiV Healthcare
2014-002281-70: Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV-1?infected patients (<100 CD4+ T cells/?L) taking antiretroviral regimens based on dolutegravir or ritonavir-boosted darunavir (the AdvanZ-4 Trial). Reconstitución inmune en pacientes con infección por el VIH-1 no tratados previamente y con cifras de linfocitos CD4+ inferiores a 100 céls/mm3 que reciben un régimen de fármacos antirretrovirales basado en dolutegravir o darunavir/ritonavir. Estudio AdvanZ-4.

Ongoing
4
108
Europe
CoatedTablet600 mg de abacavir ( sulfate) 300 mg de lamivudine, PREZISTA 300 mg comprimidos recubiertos con película darunavir, Norvir 100 mg soft tablets, Triumeq, Coated tablet, Capsule, soft, Tablet, KIVEXA( Abacavir 600 mg/ Lamivudine 300 mg) recovered tablets, PREZISTA 300 mg recovered Tablets, NORVIR 100 mg soft Tablets, TRIUMEQ®: Lamivudine(3TC) 300 mg+ Abacavir(ABC) 600 mg + dolutegravir(DGT) 50 mg : 1 comprimido
Fundació Clínic per a la Recerca Biomèdica, ViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex TW8 9GS Reino Unido
tratement HIV infection tratamiento de la infección por HIV, HIV infection infección por HIV, Diseases [C] - Virus Diseases [C02]
 
 
2015-005297-37: Bone Evaluation in women over 40 who Switch from Truvada/NNRTI to Triumeq

Ongoing
4
90
Europe
Tenofovir, Lamivudine, Efavirenz, Nevirapine, Etravirine, Rilpivirine, Film-coated tablet, Tablet, Triumeq, Truvada, Atripla, Eviplera
King's College Hospital NHS Foundation Trust, ViiV Healthcare Ltd
Human Immunodeficiency Virus, People infected with Human Immunodeficiency Virus (HIV), Diseases [C] - Immune System Diseases [C20]
 
 
2016-004646-29: DREAM study Estudio DREAM

Ongoing
4
64
Europe
Triumeq, Genvoya, Tablet, Triumeq, Genvoya
Fundación SEIMC-GESIDA, GILEAD Sciencies S.A.
HIV VIH, HIV VIH, Diseases [C] - Virus Diseases [C02]
 
 
2017-000469-62: Pilot single‐arm clinical trial to evaluate the efficacy, PK interactions and safety of dolutegravir plus 2 NRTIs in HIV‐1‐infected solid organ transplant patients. DGT-SOT Ensayo clínico piloto de un brazo para evaluar la eficacia, las interacciones farmacocinéticas y la seguridad del dolutegravir más 2 inhibidores nucleósidos de la Transcriptasa Inversa (NRTIs en su siglas en inglés) en pacientes trasplantados de órganos sólidos infectados por el VIH-1. DGT-SOT

Ongoing
4
20
Europe
Triumeq 50 mg/600 mg/300 mg comprimidos recubiertos con película dolutegravir/abacavir/lamivudina, Tivicay 50 mg, Truvada comprimidos recubiertos con película., Coated tablet, Tablet, Triumeq®, Dolutegravir 50 mg, 200 mg de emtricitabina y 245 mg de tenofovir disoproxil (equivalente a 300 mg de tenofovir disoproxil fumarato ó 136 mg de tenofovir).
Fundació Clínic per a la Recerca Biomèdica, ViiV Healthcare
HIV-1 infected solid organ transplant patients pacientes trasplantados de órganos sólidos infectados por el VIH-1., HIV-1 infected solid organ transplant patients pacientes trasplantados de órganos sólidos infectados por el VIH-1., Diseases [C] - Virus Diseases [C02]
 
 
2018-001645-14: Study to compare two treatments in patients who have never taken HIV medication randomized in different centers in Spain. (The Symtri study) Estudio para comparar dos tratamientos en pacientes que nunca han tomado medicación para el VIH asignados al azar realizado en diferentes centros de España. (Estudio SYMTRI)

Ongoing
4
316
Europe
Film-coated tablet, Symtuza, Triumeq
Spanish HIV/AIDS Research Networkº, Spanish HIV/AIDS Research Network
HIV infection Infección por VIH, HIV infection Infección por VIH, Diseases [C] - Virus Diseases [C02]
 
 
2018-001158-82: DETOX Study Estudio DETOX

Ongoing
4
110
Europe
Symtuza, Tablet, Symtuza, Triumeq
Fundación SEIMC-GESIDA, JANSSEN CILAG S.A
HIV VIH, HIV VIH, Diseases [C] - Virus Diseases [C02]
 
 
2019-004007-12: BIC CNS Study

Not yet recruiting
4
46
Europe
Biktarvy, Triumeq, Film-coated tablet, Biktarvy, Triumeq
University of Sussex, Gilead Sciences
HIV infection, HIV infection, Diseases [C] - Virus Diseases [C02]
 
 
2019-004620-38: Study to see the changes in body weight and body composition of a darunavir/cobicistat based treatment in HIV-infected people who have gained weight during a dolutegravir-based treatment. Estudio para ver los cambios en el peso y la composición del cuerpo de un tratamiento basado en darunavir/cobicistat en personas con infección por el VIH que han aumentado de peso durante un tratamiento basado en dolutegravir.

Not yet recruiting
4
60
Europe
Triumeq, Rezolsta, Kivexa, Symtuza, Film-coated tablet, Triumeq, Rezolsta, Kivexa, Symtuza
Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA
HIV infection Infección por el VIH, HIV infection Infección por el VIH, Diseases [C] - Immune System Diseases [C20]
 
 
2016-000087-42: Triumeq As an Integrase Single Tablet Regimen in People with HIV who Inject Drugs

Not yet recruiting
4
50
Europe
Triumeq, Film-coated tablet, Triumeq
University College Dublin, ViiV Healthcare
Human Immunodeficiency Virus (HIV) infection, HIV infection, Diseases [C] - Immune System Diseases [C20]
 
 
AVERTAS-1, NCT04904406: Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals

Completed
4
81
Europe
Dolutegravir / Lamivudine Oral Tablet, Dolutegravir/abacavir/lamivudine
Thomas Benfield
Hiv, HIV Infections, HIV Cardiomyopathy, Weight Change, Body, HIV Lipodystrophy, Cardiovascular Diseases
12/23
12/23
2019-004999-19: Changes in weight, body composition and metabolic parameters in HIV infected patients after switched treatment

Not yet recruiting
4
95
Europe
Tablet, Triumeq, Dovato
Department of infectious diseases, Hvidovre Hospital, The Simonsen’s Foundation
Human immunodeficiency viruses (HIV), Human immunodeficiency viruses (HIV), Diseases [C] - Virus Diseases [C02]
 
 
Moso, NCT05393193: POC HIV Testing and Early DTG Use for Infants

Active, not recruiting
4
900
RoW
Point-of-Care Cepheid Xpert HIV-1, DTG/ABC/3TC
Harvard School of Public Health (HSPH), Botswana Harvard AIDS Institute Partnership, Ragon Institute of MGH, MIT and Harvard, Botswana Ministry of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
HIV
05/26
08/26
NCT02131025: A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen

Active, not recruiting
3
428
US, Canada
ABC/DTG/3TC FDC, Ongoing cART regimen
ViiV Healthcare, PPD, GlaxoSmithKline
Infection, Human Immunodeficiency Virus
04/15
10/15
FLAIR, NCT02938520 / 2016-001646-25: Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

Active, not recruiting
3
631
Europe, Canada, Japan, US, RoW
Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA), ABC/DTG/3TC STR - Tablet, DTG Tablet
ViiV Healthcare, Janssen Pharmaceuticals, GlaxoSmithKline
HIV Infections
08/18
12/25
2018-004885-32: THE EFFECTS OF SWITCHING FROM DOLUTEGRAVIR/LAMIVUDINE/ABACAVIR (D/L/A) TO BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE (B/F/TAF) IN PATIENTS WITH SUPPRESSED VIRAL LOAD ON NEUROPSYCHIATRIC SIDE EFFECTS AND NEUROCOGNITIVE FUNCTION L’IMPATTO DEL PASSAGGIO DA DOLUTEGRAVIR/LAMIVUDINA/ABACAVIR (D/L/A) A BICTEGRAVIR/EMTRICITABINA/TENOFOVIR ALAFENAMIDE (B/F/TAF) NEI PAZIENTI IN TERAPIA ANTIRETROVIRALE CON HIVRNA SOPPRESSO SUGLI EVENTI AVVERSI NEUROPSICHIATRICI E SULLE FUNZIONI NEUROCOGNITIVE

Not yet recruiting
3
100
Europe
bictegravir/emtricitabina/tenofovir alafenamide, TRIUMEQ, [GS-9883-01], [dolutegravir/abacavir/lamivudina], Tablet, BIKTARVY, TRIUMEQ
AZIENDA OSPEDALIERA UNIVERSITARIA SENESE, Gilead Sciences
HIV-1 infection Infezione da HIV-1, Human immunodeficiency virus type 1 (HIV-1) infection Infezione da virus dell'immunodeficienza umana acquisita 1 (HIV-1), Diseases [C] - Virus Diseases [C02]
 
 
2020-005069-15: LIGHTHOUSE 2

Not yet recruiting
3
390
Europe
Triumeq, Capsule, Triumeq
Stichting TRICALS Foundation, ALS Stichting Nederland., Fight MND, Ulla-Carin Lindquist Foundation, Luzon Foundation, Research Motor Neurone
Amyotrophic Lateral Sclerosis (ALS), ALS/ Motor Neuron Disease (MND), Diseases [C] - Nervous System Diseases [C10]
 
 
2022-001437-36: ITACO study and the Analytical Antiretroviral Treatment Interruption study (ITACO-ATI) Studio ITACO e studio sull'interruzione del Trattamento Antiretrovirale (ITACO-ATI)

Not yet recruiting
3
61
Europe
ODEFSEY, REZOLSTA, BIKTARVY, Triumeq, Edurant, Tivicay, Descovy, Symtuza, Dovato, Epivir, [na], Film-coated tablet, ODEFSEY - 200 MG/25 MG/25 MG- COMPRESSA RIVESTITA- USO ORALE- FLACONE (HDPE) 30 COMPRESSE, REZOLSTA - 800 MG/ 150 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE-FLACONE (HDPE)- 30 COMPRESSE, Biktarvy, TRIUMEQ - 50MG/600MG/300 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE HDPE - 1 FLACONE 30 COMPRESSE, EDURANT - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) 30 COMPRESSE, TIVICAY - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE, DESCOVY - 200 MG/10 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- FLACONE (HDPE)- 30 COMPRESSE, Symtuza, DOVATO - 50 MG / 300 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE, EPIVIR - 300 MG 1 FLACONE 30 COMPRESSE RIVESTITE CON FILM USO ORALE
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA, NIH (Johns Hopkins University)
perinatally HIV infection Infezione da HIV perinatale, perinatally HIV infection Infezione da HIV perinatale, Diseases [C] - Immune System Diseases [C20]
 
 
2020-001426-57: A study to compare whether giving two rather than three anti-HIV medicines daily to children and young people, aged between 2 and 15 years is assafe and effective in controlling their HIV infection Ensayo para comparar si la administración de dos en vez de tres fármacos anti-VIH diariamente en niños y pacientes jóvenes entre 2 y 15 años es tan segura y efectiva en el control de su infección por VIH.

Not yet recruiting
3
370
Europe
DTG/3TC DT, Dovato, Tivicay PD, Tivicay, Triumeq, Kivexa, Ziagen, Epivir, Combivir, Retrovir, Truvada, Descovy, Dolutegravir, Dispersible tablet, Film-coated tablet, Capsule, hard, Dovato, TIVICAY PD, TIVICAY, Triumeq, Kivexa, Ziagen, Epivir, Combivir, Retrovir, Truvada, Descovy
Fondazione Penta Onlus, ViiV Healthcare UK Limited
HIV Infection Infección por VIH, HIV Infection Infección por VIH, Diseases [C] - Virus Diseases [C02]
 
 
NCT03016533: Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019

Completed
3
101
US, RoW
Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets, ABC/DTG/3TC film-coated dispersible tablets
ViiV Healthcare
HIV Infections
12/24
12/24
Lighthouse III, NCT06658977: RolloverTreatment With Triumeq for People With ALS Following the Lighthouse II Trial

Enrolling by invitation
3
70
RoW
Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq)
Macquarie University, Australia
Amyotrophic Lateral Sclerosis, ALS
12/26
12/26
LIGHTHOUSE II, NCT05193994: Triumeq in Amyotrophic Lateral Sclerosis

Active, not recruiting
3
390
Europe, RoW
Dolutegravir, Abacavir and Lamivudine, Triumeq, Placebo
Macquarie University, Australia, King's College London, Stichting TRICALS Foundation
Amyotrophic Lateral Sclerosis
06/25
06/25
Tivicay (dolutegravir) / ViiV Healthcare
2013-003704-39: CV risk in HIV patients switching from a boosted PI to DTG

Ongoing
4
112
Europe
Dolutegravir, Darunavir, Atazanavir, Kaletra, Ritonavir, Fosamprenavir, INVIRASE, Tivicay, Prezista, Reyataz, Kaletra, Norvir, Telzir, Invirase, Tivicay, Prezista, Reyataz, Kaletra, Norvir, Telzir, Invirase
St Stephen\'s AIDS Trust, NEAT-ID, Viiv Healthcare Ltd
HIV infection
 
 
InMIND, NCT02406196: Integrase and Maraviroc Intensification for Neurocognitive Dysfunction

Not yet recruiting
4
186
NA
Placebo for MVC, Maraviroc, MVC, Placebo for DTG, Dolutegravir, DTG
AIDS Clinical Trials Group, National Institute of Allergy and Infectious Diseases (NIAID)
HIV-1 Infection
06/17
06/18
2019-000199-41: A study to evaluate the impact of the change of antiretroviral treatment from dual therapy to triple therapy on inflammation in HIV+ patients. Estudio para evaluar el impacto del cambio de tratamiento antirretroviral de terapia dual a terapia triple sobre la inflamación en pacientes VIH +

Not yet recruiting
4
234
Europe
Bictarvy, Tivicay, Epivir, Tablet, Bictarvy, Tivicay, Epivir
Fundación SEIMC-GESIDA, Gilead Sciences, S.L
HIV VIH, HIV VIH, Diseases [C] - Virus Diseases [C02]
 
 
2019-002733-10: Exploratory, open-label, randomized clinical trial to assess the efficacy of first-line dual vs. triple antiretroviral therapy (art) in hiv-1 reservoir and in peripheral compartments in hiv-infected patients. Ensayo clínico abierto, aleatorizado para evaluar el efecto del tratamiento antirretroviral inicial doble vs.triple en el reservorio del VIH-1 y en tejidos periféricos en pacientes infectados por el VIH-1.

Ongoing
4
44
Europe
Coated tablet, Tivicay, Descovy, Lamivudine
FUNDACIÓ LLUITA CONTRA LA SIDA, Viiv Healthcare
HIV infection Infección por VIH, HIV infection Infección por VIH, Diseases [C] - Virus Diseases [C02]
 
 
ChiCTR1900027640: A real world study for a simplified regimen of dolutegravir combined with lamivudine in the treatment of newly infected HIV patients

Not yet recruiting
4
30
 
DTG 50mg +3TC 300mg once a day
The Fifth Affiliated Hosipital Of Sun Yat-sen University; The Fifth Affiliated Hosipital Of Sun Yat-sen University, Hospital funding and self-finacing
HIV/AIDS
 
 
ChiCTR1900027321: Prospective, non-inferior, randomized controlled trial of post-exposure prevention regimens for HIV

Not yet recruiting
4
276
 
Once a day with Elvitegravir150mg/Cobicistat 150mg/Emtricitabine200mg/Tenofovir AlafenamideFumarate 10mg Tablets ;Lamiwudine300mg/Tenofovir Disoproxl1 Pumarnte Tablets 300mg once a day plus Dolutegravir Sodium Tablets 50mg once a day
the Fifth Affiliated Hospital of Sun Yat-sen University; The fifth affiliated hospital of sun yat-sen university, self-finacing
AIDS
 
 
NCT02800655: Digital Health Feedback System for Longitudinal Measurement of Medication Adherence During Anti-Retroviral (ARV)Therapy

Active, not recruiting
4
100
US
Digital Health Feedback System
University of California, San Diego, National Institute of Mental Health (NIMH), Gilead Sciences, ViiV Healthcare, GlaxoSmithKline, Proteus Digital Health, Inc.
HIV
12/21
12/23
NCT04340388: Contribution of Dolutegravir to Obesity and Cardiovascular Disease

Completed
4
10
US
Dolutegravir 50 MG, Tenofovir alafenamide, Tenofovir disoproxil fumarate, Abacavir, Lamivudine, Darunavir, Cobicistat, Rilpivirine, Combivir, Zidovudine, Antiretroviral/Anti HIV, Antiretroviral Combinations
Augusta University
HIV-1-infection, Antiviral Drug Adverse Reaction, Vascular Diseases, Cardiovascular Abnormalities, Abnormality of Adipose Tissue, Body Weight Changes, Body Fat Disorder, HIV-Associated Lipodystrophy Syndrome
06/22
02/23
2018-003458-26: Evaluating inflammatory and immunological changes of HIV-positive patients switching to DTG dual regimen compared to those switching to a triple drugs regimen (B/F/TAF). Valutazione dei cambiamenti a livello infiammatorio e immunologico nei pazienti con infezione da HIV che passano a un doppio regime terapeutico contenente DTG rispetto a quelli che passano a un triplo regime (B/F/TAF).

Not yet recruiting
4
66
Europe
lamivudina, dolutegravir, bictegravir/emtricitabina/tenofovir alafenamide fumarato, [3TC], [DTG], [B/F/TAF], Film-coated tablet, Biktarvy
AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA, Gilead Sciences Inc.
HIV infection infezione da HIV, HIV infection infezione da HIV, Diseases [C] - Virus Diseases [C02]
 
 
ORCHID, NCT04746547: Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children With HIV and TB

Recruiting
4
20
RoW
Dolutegravir 50 MG, Dolutegravir 10 MG
University of KwaZulu, Centre for the AIDS Programme of Research in South Africa
Tuberculosis, Hiv
07/25
07/25
ChiCTR2100045021: Drug concentration monitoring of albuvirtide/dolutegravir in the treatment of HIV-1 patients with end-stage renal disease

Recruiting
4
10
 
Albuvirtide and dolutegravir
Chongqing Public Health Medical Center; Chongqing Public Health Medical Center, Chongqing Red-ribbon HIV/AIDS Care Center
HIV
 
 
ChiCTR2300072308: Study on the efficacy and safety of Dolutegravir combined with Lamivudine in the treatment of HIV infections

Completed
4
72
 
None ;None
Chest Hospital of Guangxi Zhuang Autonomous Region (Longtan Hospital of Guangxi Zhuang Autonomous Region); Chest Hospital of Guangxi Zhuang Autonomous Region (Longtan Hospital of Guangxi Zhuang Autonomous Region), Scientific and technological funds provided by Guangxi Liuzhou Science and Technology Bureau, self-owned funds of Chest Hospital of Guangxi Zhuang Autonomous Region (Longtan Hospital)
Acquired immune deficiency syndrome
 
 
CODA, NCT04910711: Investigating the Interaction Between Two Long-acting Reversible Methods of Contraception and Dolutegravir, a Treatment for HIV

Active, not recruiting
4
140
RoW
Dolutegravir, Levonorgestrel implant, Depo medroxyprogesterone acetate injection
Botswana Harvard AIDS Institute Partnership, University of Liverpool
Human Immunodeficiency Virus, Contraception, ART
08/23
10/24
DoRIS, NCT04166474: Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

Completed
4
36
RoW
Dolutegravir
Helen Reynolds, Infectious Disease Institute, Kampala, Uganda, Desmond Tutu HIV Centre
Hiv, Tuberculosis
02/24
02/24
DoraDO, NCT05630638: Doravirine Dose Optimisation in Pregnancy

Recruiting
4
76
RoW
Doravirine, Delstrigo, Dolutegravir, TLD
University of Liverpool, Liverpool School of Tropical Medicine, Desmond Tutu Health Foundation
HIV
11/25
02/26
OPTIMAL, NCT04708496: Optimizing Malaria Treatment for HIV-Malaria Co-infected Individuals

Recruiting
4
888
RoW
Artemether-lumefantrine, Efavirenz, Dolutegravir
Makerere University
HIV Coinfection, Malaria
01/24
03/24
 

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