| Tivicay (dolutegravir) / ViiV Healthcare |
| 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] | | | | |
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. |
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| 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] | | | | |
2015-000274-35: 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. |
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| 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] | | | | |
| 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 | | | | |
| 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 | | | | |
| 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 | | |
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 |
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| 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] | | | | |
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. |
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| 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] | | | | |
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 + |
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| 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. |
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| 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] | | | | |
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. |
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| 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] | | | | |
ChiCTR1900027640: A real world study for a simplified regimen of dolutegravir combined with lamivudine in the treatment of newly infected HIV patients |
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| 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 |
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| 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 |
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| 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 |
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| 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). |
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| 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] | | | | |
| 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 |
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| 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 |
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| 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 |
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| 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 | | |
| Completed | 4 | 36 | RoW | Dolutegravir | Helen Reynolds, Infectious Disease Institute, Kampala, Uganda, Desmond Tutu HIV Centre | Hiv, Tuberculosis | 02/24 | 02/24 | | |
2019-004999-19: Changes in weight, body composition and metabolic parameters in HIV infected patients after switched treatment |
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| 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] | | | | |
| 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 | | |
| Recruiting | 4 | 888 | RoW | Artemether-lumefantrine, Efavirenz, Dolutegravir | Makerere University | HIV Coinfection, Malaria | 01/24 | 03/24 | | |
| Completed | 4 | 155 | RoW | Darunavir (DRV) 800 milligram (MG) Oral Tablet, Prezista, Ritonavir 100 MG Oral Tablet, Norvir, RTV, N(t)RTIs, Nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs], Dolutegravir 50 MG Oral Tablet, Tivicay, DTG, TDF 300 MG Oral Tablet, tenofovir disoproxil fumarate, Viread, 3TC 300 MG Oral Tablet, lamivudine, FTC 200 MG Oral Cap, Emtriva, emtricitabine | Kirby Institute | HIV Infections | 01/24 | 01/24 | | |
DGVTAF, NCT02656511: Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection |
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| Active, not recruiting | 4 | 74 | US | Dolutegravir, Tivicay, Emtricitabine/Tenofovir, Truvada | University of California, San Francisco, ViiV Healthcare, Gilead Sciences | HIV | 05/27 | 05/28 | | |
| Recruiting | 4 | 40 | RoW | Liraglutide, Saxenda | Brigham and Women's Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Obesity, HIV Infections | 05/25 | 05/25 | | |
| Terminated | 4 | 18 | Europe | DELSTRIGO 100Mg-300Mg-300Mg Tablet | Chelsea and Westminster NHS Foundation Trust, Merck Sharp & Dohme LLC | Hiv | 11/24 | 11/24 | | |
ChiCTR2200058014: Pharmacokinetics, Safety and Efficacy of Albuvirtide in HIV-1 Patients with End Stage Renal Disease Requiring Hemodialysis |
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| Not yet recruiting | 4 | 10 | | The first stage: Albvirtide+Dolutegravir+Lamifudine; The second stage: Albvirtide+Dolutegravir | Chongqing Public Health Medical Center; Chongqing Public Health Medical Center, Frontier Biotechnologies Inc. | Acquired Immune Deficiency Syndrome | | | | |
ChiCTR2300073588: Study on the efficacy, pharmacokinetics and safety of the combination of intravenous and oral Dolutegravir antiretroviral regimens every 4 weeks in Virology to inhibit stable conversion of HIV infected people for 24 weeks |
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| Not yet recruiting | 4 | 10 | | ABT 640mg, administered every 4 weeks, intravenous drip | Guiyang public treatment center; Guiyang public treatment center, Self-raised by researchers | HIV | | | | |
MAFALDA-R, NCT05898841: Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load |
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| Active, not recruiting | 4 | 75 | Europe | Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day, Tenofovir disoproxil fumarate (TDF) 245 mg per day or Tenofovir alafenamide (TAF) 25 mg per day + Emtricitabine (FTC) 200 mg per day + Rilpivirine 25 mg per day, Continue with their previous treatment. Any previous HAART that does not contain Rilpivirine. | Fundacion SEIMC-GESIDA | HIV Infections, Fatty Liver Disease | 01/25 | 04/25 | | |
| Active, not recruiting | 3b/4 | 831 | RoW | NRTIs, Nucleoside/Nucleotide Reverse Transcription Inhibitors, Dolutegravir, Tivicay, Darunavir, Prezista, Ritonavir, Norvir | Kirby Institute, UNITAID, National Institute of Allergy and Infectious Diseases (NIAID), National Health and Medical Research Council, Australia, ViiV Healthcare, Janssen Pharmaceutica | HIV Infections | 11/22 | 10/23 | | |
2021-000243-50: Understanding the Impact of HIV-DNA resistance mutations detected by NGS in Simplificationstrategies to 2-Drug Regimens for patients virologically suppressed with previous failures and/orprevious resistance mutations: a prospective multi-centre intervention study (INS-2DR) Impatto delle mutazioni di resistenza rilevate su HIV-DNA con NGS nelle strategie di Semplificazione a regimi a due farmaci in pazienti HIV+ virologicamente soppressi con pregressi fallimenti virologici e/o pregresse mutazioni di resistenza: uno studio prospettico interventistico multi-centrico (INS-2DR) |
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| Not yet recruiting | 3 | 210 | Europe | Lamivudina, Pifeltro, Emtriva, Juluca, Janssen-Cilag International NV, Tivicay, Dovato, [-], Tablet, Film-coated tablet, Capsule, hard, Coated tablet, Lamivudina, Pifeltro, Emtriva, Juluca, EDURANT, Tivicay, Dovato | ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI", Ministero della salute | HIV infection Infezione da HIV, HIV infection Infezione da HIV, Diseases [C] - Virus Diseases [C02] | | | | |
2016-002413-22: Open label, Randomized clinical trial to evaluate switching from dual regimens to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in virologically suppressed, HIV-1 infected patients Studio in aperto, randomizzato, per valutare il passaggio da una terapia duplice ad una terapia con E/C/F/TAF in pazienti adulti HIV positivi con carica virale negativa. |
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| Ongoing | 3 | 100 | Europe | Tivicay (dolutegravir), Emtriva, Lamivudina, Viread, Ziagen, Edurant, Intelence, Sustiva, Viramune, Film-coated tablet, Capsule, hard, Tablet, Prolonged-release tablet, Genvoya¿ 150 mg/150mg/200mg/10mg, TIVICAY - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE, EMTRIVA - 30 CAPSULE RIGIDE IN BLISTER DA 200 MG, LAMIVUDINA MYLAN - 300 MG COMPRESSE RIVESTITE CON FILM 30 COMPRESSE IN BLISTER PVC/PVDC/AL, VIREAD - 245 MG 30 COMPRESSE RIVESTITE CON FILM IN FLACONE USO ORALE, ZIAGEN - 300 MG COMPRESSE FILMRIVESTITE 6 BLISTER 10 COMPRESSE USO ORALE, EDURANT - 25 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) 30 COMPRESSE, INTELENCE - 200 MG - COMPRESSA -USO ORALE - FLACONE (HDPE) 60 COMPRESSE, SUSTIVA - 600 MG COMPRESSE FILM RIVESTITE 1 FLACONE 30 COMPRESSE USO ORALE, VIRAMUNE - 400 MG - COMPRESSA A RILASCIO PROLUNGATO - USO ORALE - BLISTER (PVC/AL) 30 COMPRESSE | OSPEDALE SAN RAFFAELE, Gilead Sciences Inc. | HIV infection Infezione da HIV, HIV infected subjects pazienti affetti da virus HIV, Diseases [C] - Virus Diseases [C02] | | | | |
| Completed | 3 | 268 | RoW | Dolutegravir, Standard of Care (EFV + 2 NRTI backbone) | University of Liverpool, UNITAID, University of Cape Town, Liverpool School of Tropical Medicine, Infectious Diseases Institute, Uganda, Radboud University Medical Center | HIV-1-infection, Pregnancy Related | 10/20 | 09/23 | | |
2020-003951-13: Dual therapy in HIV patients in 4 days a week versus 7 days a week Bithérapie chez des patients HIV en 4 jours sur 7 versus 7 jours sur 7 |
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| Not yet recruiting | 3 | 440 | Europe | Film-coated tablet, TIVICAY, EPIVIR, PREZISTA, EDURANT, NORVIR | INSERM-ANRS, ANRS | HIV infection Infection par le VIH, HIV infection Infection par le VIH, Diseases [C] - Virus Diseases [C02] | | | | |
ALLIANCE, NCT03547908 / 2018-000926-79: Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults |
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| Completed | 3 | 244 | Europe, Japan, US, RoW | B/F/TAF, Biktarvy®, Placebo to match DTG, Placebo to match F/TDF, DTG, F/TDF, Truvada®, Placebo to match B/F/TAF | Gilead Sciences | HIV-1/HBV Co-Infection | 02/22 | 03/24 | | |
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) |
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| 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. |
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| 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] | | | | |
| Active, not recruiting | 3 | 360 | Europe | Antiretroviral | ANRS, Emerging Infectious Diseases, Institut National de la Santé Et de la Recherche Médicale, France | HIV-1-infection | 09/23 | 03/24 | | |
LAPIS, NCT06250504: Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT |
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| 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 | | |
| Not yet recruiting | 3 | 70 | RoW | Abacavir 600mg, Lamivudine 300mg and Dolutegravir 50mg (Triumeq) | Macquarie University, Australia | Amyotrophic Lateral Sclerosis, ALS | 12/26 | 12/26 | | |
| Active, not recruiting | 3 | 540 | RoW | Cabotegravir/Rilpivirine, Vocabria/Rekambys, Antiretroviral, 2NRTIs + dolutegravir 50mg once daily | MRC/UVRI and LSHTM Uganda Research Unit, Janssen Pharmaceuticals | HIV-1-infection | 04/25 | 03/26 | | |
NCT06747507: Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance |
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| Not yet recruiting | 3 | 392 | RoW | Dolutegravir Pill, Darunavir+Ritonavir, Durart | University of Nairobi, Instituto Nacional de Saúde, Mozambique, Muhimbili University of Health and Allied Sciences, SolidarMed Lesotho, London School of Hygiene and Tropical Medicine | HIV-1-infection | 08/26 | 02/27 | | |
| Not yet recruiting | 3 | 290 | Europe | Antiviral Agents | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | HIV Infections | 09/25 | 09/25 | | |
DORDOL, NCT04892654: Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch |
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| Recruiting | 3 | 150 | Europe | Doravirine, Pifeltro, Dolutegravir, Tivicay, Triple cART regimen | Chelsea and Westminster NHS Foundation Trust | HIV-1-infection | 11/26 | 11/27 | | |
| Recruiting | 3 | 722 | RoW | HAART, Kivexa, Tivicay | South East Asia Research Collaboration with Hawaii, Thai Red Cross AIDS Research Centre, Pfizer, Gilead Sciences, Merck Sharp & Dohme LLC, ViiV Healthcare | Acute HIV Infection, Chronic HIV Infection | 06/33 | 06/33 | | |
ODYSSEY, NCT02259127 / 2014-002632-14: A Randomised Trial of Dolutegravir (DTG)-Based Antiretroviral Therapy vs. Standard of Care (SOC) in Children With HIV Infection Starting First-line or Switching to Second-line ART |
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| Active, not recruiting | 2/3 | 792 | Europe, RoW | DTG | PENTA Foundation, Institut National de la Santé Et de la Recherche Médicale, France, Program for HIV Prevention and Treatment (PHPT), Medical Research Council Clinical Trials Unit at University College London (MRC CTU at UCL) | HIV Infection | 06/21 | 05/23 | | |
D3 (Penta21), NCT04337450: DTG/3TC Fixed Dose Formulations for the Maintenance of Virological Suppression in Children with HIV Infection Aged 2 to <15 Years Old |
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| Recruiting | 2/3 | 370 | Europe, RoW | Dolutegravir (DTG) and lamivudine (3TC), SOC | PENTA Foundation, MRC CTU at UCL, AMS-CMU/IRD (PHPT), Chris Hani Baragwanath Academic Hospital, Durban International Clinical Research Site, Hospital Universitario 12 de Octubre, Prapokklao Hospital, Chantaburi, Chiangrai Prachanukroh Hospital, Nakornping Hospital, Khon Kaen Hospital, Kalasin Hospital, Joint Clinical Research Center, MU-JHU CARE, Baylor College of Medicine, Great Ormond Street Hospital for Children NHS Foundation Trust, University Hospital Birmingham NHS Foundation Trust, Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands., Advanced Pathogens Diagnostics Unit, University College London Hospitals, Centre for Health Economics, University of York, Department of Molecular and Clinical Pharmacology, University of Liverpool, Chang Mai Univerity, St Mary's Hospital, London | HIV Infections | 09/25 | 09/25 | | |
ACTRN12621000937819p: A study of the safety and efficacy of 6 months treatment with BIT225 and Combination Antiretroviral Therapy (cART) in patients with Human Immunodeficiency Virus-1 (HIV-1) compared to cART alone, including measurement of BIT225 in the blood, antiviral activity and immune markers. |
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| Not yet recruiting | 2 | 27 | | | Biotron Limited, Biotron Limited | Human Immunodeficiency Virus-1 infection | | | | |
2015-001206-33: A pilot phase II study of a nucleoside sparing regimen of Dolutegravir + Atazanavir/r in HIV-1 infected patients with detectable viremia (Dolatav Study) Studio pilota, in aperto, sull'efficacia di un regime non contenente farmaci nucleosidici, con atazanavir/ritonavir associato a dolutegravir in pazienti con carica virale positiva (Studio Dolatav) |
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| Not yet recruiting | 2 | 40 | Europe | Reyataz 300 mg, Norvir 100 mg, Tivicay, Reyataz 200 mg, A71IL, Capsule, hard, Film-coated tablet, REYATAZ - 300 MG CAPSULE RIGIDE - USO ORALE-FLACONE (POLIETILENE AD ALTA DENSITA') 30 CAPSULE, NORVIR - 100 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE(HDPE) 30 COMPRESSE, TIVICAY - 50 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE, REYATAZ - 200 MG 60 CAPSULE IN BLISTER USO ORALE | OSPEDALE SAN RAFFAELE, Bristol-Myers Squibb S.r.l | HIV-1 infected patients pazienti affetti da virus HIV-1, pazienti affetti da infezione da HIV-1, Diseases [C] - Virus Diseases [C02] | | | | |
NCT05006170: Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV |
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| Recruiting | 2 | 30 | RoW | DTG DT 20 mg, MYLTEGA Dispersible Tablet, DTG DT 25 mg, MYLTEGA DT Dispersible Tablet | Chulalongkorn University | Pediatric HIV Infection | 02/22 | 06/22 | | |
NCT03602690: Evaluation of Third-line cART Regimen in Cambodia (3DICAM) |
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| Recruiting | 2 | 54 | RoW | Dolutegravir + Darunavir/ritonavir + optimized NRTI | ANRS, Emerging Infectious Diseases | HIV/AIDS | 04/22 | 04/22 | | |
ACTRN12621000937819: A study of the safety and efficacy of 6 months treatment with BIT225 and Combination Antiretroviral Therapy (cART) in patients with Human Immunodeficiency Virus-1 (HIV-1) compared to cART alone, including measurement of BIT225 in the blood, antiviral activity and immune markers. |
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| Completed | 2 | 27 | | | Biotron Limited, Biotron Limited | Human Immunodeficiency Virus-1 infection | | | | |
| Terminated | 2 | 161 | Europe, Canada, US, RoW | GSK3640254, ABC/3TC, FTC/TAF, Dolutegravir, Placebo | ViiV Healthcare | HIV Infections | 09/22 | 05/23 | | |
| Terminated | 2 | 85 | Europe, Canada, US, RoW | GSK3640254, Dolutegravir, Lamivudine capsules, Lamivudine tablets | ViiV Healthcare, Syneos Health | HIV Infections | 11/22 | 05/23 | | |
NCT05630872: Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis |
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| Active, not recruiting | 2 | 30 | RoW | Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC, DTG 50 mg orally QD plus TDF/3TC, 2HPZM, 2HPM | National Institute of Allergy and Infectious Diseases (NIAID), ViiV Healthcare, Mylan Inc. | HIV-associated Tuberculosis | 02/25 | 09/25 | | |
NCT03731559: Efficacy, Safety and Pharmacokinetics of DTG with RIF |
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| Recruiting | 2 | 200 | RoW | DTG 50 mg OD with food, DTG 50 mg BID | The HIV Netherlands Australia Thailand Research Collaboration, Chest Division, Chulalongkorn University, Infectious Disease, Chulalongkorn University, Bamrasnaradura Infectious Diseases Institute, Bhumibol Adulyadej Hospital, Infectious Disease Taksin Hospital, Klang Hospital, Infectious Disease Chiangrai Prachanukroh Hospital, Infectious Disease Chonburi Hospital, Infectious Disease Buddhachinaraj Phitsanulok Hospital, Radboud University Medical Center, Department of Disease Control, Ministry of Public Health (MOPH), Thailand | HIV/TB Coinfection | 06/25 | 06/25 | | |
| Completed | 1/2 | 181 | US, RoW | DTG film-coated tablets, DTG granules for suspension, DTG dispersible tablets | National Institute of Allergy and Infectious Diseases (NIAID) | HIV Infections | 01/21 | 10/23 | | |
| Recruiting | 1/2 | 56 | RoW | Dolutegravir | Desmond Tutu TB Centre, Chiang Mai University, UNITAID, University of Stellenbosch | Hiv | 06/24 | 12/24 | | |
DOLPHIN Moms, NCT05122026: Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics of Dolutegravir (DTG) in Pregnant People With HIV |
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| Recruiting | 1/2 | 252 | RoW | Rifapentine, Priftin, Isoniazid, Winthrop Isoniazid | The Aurum Institute NPC, Johns Hopkins University, Weill Medical College of Cornell University, University of Washington | HIV Seropositivity, Pregnancy, Tuberculosis Infection | 12/24 | 03/25 | | |
DOLPHIN KIDS, NCT05122767: Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment |
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| Recruiting | 1/2 | 92 | RoW | Dolutegravir, 3HP | The Aurum Institute NPC, Johns Hopkins University | Tuberculosis, HIV | 12/24 | 12/25 | | |
| Recruiting | 1 | 64 | RoW | Dotilavir sodium tablet, Dotilavir sodium tablet(Tivicay@) | The Affiliated Hospital of Qingdao University | Healthy Volunteers | 12/21 | 01/22 | | |
NCT05526911: A Phase 1, Drug-Drug Interaction Study of TBAJ-876 in Healthy Adults |
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| Completed | 1 | 28 | US | TBAJ-876, Midazolam, Digoxin | Global Alliance for TB Drug Development | Pulmonary Disease, Tuberculosis, Pulmonary, Tuberculosis, Multi Drug Resistant Tuberculosis, Drug Sensitive Tuberculosis, Drug-resistant Tuberculosis, Mycobacterium Tuberculosis Infection | 09/22 | 09/22 | | |
NCT02437110: HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) |
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| Completed | 1 | 122 | US | Darunavir, Ritonavir, Dolutegravir, Tenofovir alafenamide (TAF) | National Institute of Neurological Disorders and Stroke (NINDS) | Amyotrophic Lateral Sclerosis | 11/22 | 05/23 | | |
| Completed | 1 | 16 | Europe | DTG DT (6 x 5 mg), Tivicay 5 mg (ViiV), F/TAF TOS (3 x 60/7.5 mg), F/TAF TOS 60/7.5 mg (Gilead) | Radboud University Medical Center, Gilead Sciences | Hiv | 03/23 | 11/23 | | |
NCT04771754: The Effect of Dolutegravir on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers |
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| Completed | 1 | 16 | Europe | Dolutegravir, Tivicay | Chelsea and Westminster NHS Foundation Trust | HIV-1-infection on Healthy Volunteers | 12/23 | 01/24 | | |
NCT06450275: Bioequivalence Study to Compare Dolutegravir 50mg Film-coated Tablets |
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| Completed | 1 | 32 | RoW | Dolutegravir 50 MG Film Coated Tablet, Tivicay 50mg, film-coated tablets | Humanis Saglık Anonim Sirketi | HIV Infections | 01/24 | 03/24 | | |
NCT05406583: A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1 |
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| Recruiting | 1 | 36 | US, RoW | Dolutegravir 0.5 mg/kg oral suspension, DTG, Dolutegravir 5 mg Dispersible Tablets | National Institute of Allergy and Infectious Diseases (NIAID), ViiV Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH) | HIV | 09/25 | 11/25 | | |
NCT06281834: Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention |
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| Recruiting | 1 | 25 | RoW | Rifapentine, Dolutegravir | Brigham and Women's Hospital, APIN Public Health Initiatives, University of Cape Town | Pediatric HIV Infection, Latent Tuberculosis | 02/27 | 06/27 | | |
NCT05069688: Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin |
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| Recruiting | 1 | 20 | RoW | rifampicin | Brigham and Women's Hospital, APIN Public Health Initiatives, University of Cape Town | Pediatric HIV Infection, Tuberculosis Infection | 03/25 | 03/25 | | |
NCT02028819: Compassionate Use of Ibalizumab for the Treatment of HIV Infection |
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| No Longer Available | N/A | | US | Dolutegravir Sodium Monohydrate, TIVICAY, Ibalizumab, TMB-355 | University of Colorado, Denver | Human Immunodeficiency Virus (HIV) | 02/14 | 02/14 | | |
| Completed | N/A | 1433 | RoW | Dolutegravir | Swiss Tropical & Public Health Institute, SolidarMed, Ministry of Health, Lesotho, District Health Management Team of Butha-Buthe, Lesotho, District Health Management Team of Mokhotlong, Lesotho, University of Basel | HIV-1-infection | 05/21 | 05/21 | | |
MICTLAN, NCT06629480: Incidence of Metabolic Syndrome in People Living With HIV Without ExperienCe to ART Who Start DoLutegravir Based-Regimen Compared With BictegrAvir Based-RegimeN |
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| Completed | N/A | 378 | RoW | Bictegravir | Instituto Mexicano del Seguro Social | Antiretroviral Treatment, HIV Infection, Metabolic Cardiovascular Syndrome | 02/24 | 02/24 | | |
| Recruiting | N/A | 2600 | RoW | | University of Bern, University of Zurich, ETH Zurich, University of KwaZulu, University of Bristol | Hiv | 08/25 | 08/25 | | |
| 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 | | |
| Active, not recruiting | N/A | 118 | Europe | Cultural Domain Analysis, Focus Group Discussion, In-depth interview | University of Sussex, Brighton and Sussex University Hospitals NHS Trust | HIV Infections | 07/22 | 07/22 | | |
CHARACTERISE, NCT05502692: - A Cross-sectional, Observational Study to Characterise the Transition to Dolutegravir-based Regimens in South Africa in Terms of the Emergence of Obesity, Viral Re-suppression and Integration Into Routine Programme Care |
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| Completed | N/A | 200 | RoW | CHARACTERISE | University of Witwatersrand, South Africa, UNITAID | Dolutegravir | 12/22 | 03/23 | | |
DTG-SWITCH, NCT04612452: The Study: Longitudinal Analysis of Virologic Failure and Drug Resistance at and After Switching to Dolutegravir-based First-line ART |
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| Completed | N/A | 2820 | RoW | | University of Bern, University of KwaZulu, Lighthouse Trust, Centre for Infectious Disease Research in Zambia | Hiv, Drug Resistancy, Virologic Failure | 03/23 | 03/23 | | |
NCT03564613: Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women |
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| Recruiting | N/A | 250 | Europe | DTG | ViiV Healthcare | HIV Infections | 10/24 | 10/24 | | |
DISCO, NCT04066036: Population Effectiveness of Dolutegravir Implementation in Sub-Saharan Africa |
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| Completed | N/A | 1000 | RoW | This is an observational study only. | Massachusetts General Hospital, Africa Health Research Institute, Mbarara University of Science and Technology, National Institute of Allergy and Infectious Diseases (NIAID), Wellcome Trust, ViiV Healthcare, Harvard Medical School (HMS and HSDM), University of KwaZulu, Emory University | HIV-1-infection | 05/23 | 05/23 | | |
DOLUVOIR, NCT04133012: Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing Dolutegravir and Associated Nucleoside / Nucleotide Reverse Transcriptase Inhibitors Backbone |
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| Completed | N/A | 20 | NA | Samplings | ANRS, Emerging Infectious Diseases, ViiV Healthcare | HIV-1 Infection | 06/23 | 06/23 | | |
| Completed | N/A | 180 | Europe | Dolutegravir, Bictegravir | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | HIV Infections | 12/23 | 12/23 | | |
| Recruiting | N/A | 5000 | RoW | No intervention | Fundação Bahiana de Infectologia, University of New Mexico, Instituto Infectologia Evandro Chagas, Rio de Janeiro, Fundação de Medicina Tropical de Manaus, Hospital de Clinicas de Porto Alegre, Centro de Referência e Tratamento, CRT, São Paulo, SP, Hospital Partenon, Porto Alegre, Universidade Municipal de São Caetano do Sul, Universidade Federal do Rio Grande do Norte, Hospital Universitário Cassiano Antônio de Moraes/HUCAM, Hospital das Clínicas da Faculdade de Medicina de Ribeirao Preto/USP, Faculdade de Medicina de Botucatu, Unesp, Sociedade Campineira de Educação e Instrução - Campinas, Fundação Universidade de Caxias do Sul - FUCS/RS | HIV Infections, Clinical Outcomes, Adverse Drug Event, Effect of Drugs | 12/24 | 02/25 | | |
LoDoCA, NCT05426421: Tolerability of Lopinavir Versus Dolutegravir for Children and Adolescents Living With HIV |
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| Completed | N/A | 258 | RoW | | Swiss Tropical & Public Health Institute, University Hospital, Basel, Switzerland, University of Basel, University of Zurich, Baylor International Pediatric AIDS Initiative, Lesotho Ministry of Health, Baylor College of Medicine Children's Foundation Lesotho | HIV | 09/23 | 09/23 | | |
NCT05883761: Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment |
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| Completed | N/A | 50075 | RoW | | Elizabeth Glaser Pediatric AIDS Foundation, Ministry of Health Eswatini, George Washington University | Neural Tube Defects, Congenital Abnormalities, Teratogens | 09/23 | 09/23 | | |
ChiCTR2000038952: An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With EVG/c/TAF/FTC in Treatment HIV Infected Subjects with Virologically-Suppressed Experienced Subjects |
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| Recruiting | N/A | 420 | | 3TC+DTG ;EVG/c/TAF/FTC | Shanghai Public Health Clinical Center; Shanghai Public Health Clinical Center, Shanghai public health clinical center | AIDS | | | | |
| Recruiting | N/A | 200 | RoW | Not applicable- observational study | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | HIV, HIV Antiretroviral Therapy (ART) Adherence | 04/25 | 09/25 | | |
BMS02, NCT04862975: Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana |
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| Recruiting | N/A | 200 | RoW | Dolutegravir, Dolutegravir Sodium, DTG, Lamivudine, 3TC, Emtricitabine, FTC, Tenofovir Disoproxil Fumarate, Tenofovir DF, TDF | Duke University, The Emmes Company, LLC | Lactating Women on Select DOI, Breastmilk Fed Infants of Mothers on Select DOI, HIV Infections | 12/24 | 12/24 | | |
ORCHID, NCT04991402: Obesogenic Origins of Maternal and Child Metabolic Health Involving Dolutegravir |
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| Active, not recruiting | N/A | 1920 | RoW | Dolutegravir-based antiretroviral therapy | Columbia University, Northwestern University, University of Cape Town, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Hawaii, Tufts University, Albert Einstein College of Medicine | HIV, Obesity, Obesity, Infant, Maternal Obesity During Childbirth, Maternal Obesity Complicating Pregnancy | 12/24 | 12/24 | | |
NCT00537966: Characterization of Acute and Recent HIV-1 Infections in Zurich. |
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| 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 | | |
NCT06762054: Investigating the Optimal Management of Dolutegravir Resistance |
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| Not yet recruiting | N/A | 6600 | RoW | Continue DTG-based antiretroviral therapy, Enhanced adherence counselling | University of Nairobi, Instituto Nacional de Saúde, Mozambique, Muhimbili University of Health and Allied Sciences, SolidarMed Lesotho, London School of Hygiene and Tropical Medicine | HIV-1-infection | 10/26 | 10/26 | | |
NCT06805656: Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals |
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| Not yet recruiting | N/A | 70 | RoW | Maraviroc, Selzentry, Celsentri, Dolutegravir, Tivicay, Dendritic Cell Vaccine, DC Vaccine, Auranofin, Gold Salt, Sirtuin Histone deacetylase inhibitor, Nicotinamide | Federal University of São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico | Hiv, HIV I Infection | 07/26 | 12/27 | | |
NCT04518228: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum |
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| Recruiting | N/A | 325 | 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 | | |
RESOLVE, NCT05373758: A Randomized Clinical Trial to Evaluate Solutions for the Management of Virologic Failure on TLD in Sub-Saharan Africa |
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| Recruiting | N/A | 648 | RoW | Standard of Care treatment strategy, Individualized Care treatment strategy, Immediate Switch | Massachusetts General Hospital, Mbarara University of Science and Technology, University of KwaZulu, University of California, San Francisco, National Institute of Allergy and Infectious Diseases (NIAID) | HIV Infections, AIDS, Virologic Failure | 05/27 | 05/27 | | |
NCT05312918: Large Scale Transition to a Dolutegravir-based First-line ART in the South: Virological Response and Impact on HIV Drug Resistance in a Real Life Context (DoReaL Study) |
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| Not yet recruiting | N/A | 603 | RoW | | ANRS, Emerging Infectious Diseases, CIRBA, Abidjan, Ivory Coast, SEREFO, Bamako, Mali, BIOLIM/FSS/UL, Lomé, Togo | HIV Infections | 03/23 | 10/24 | | |
