| Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead |
2018-003880-79: Switch from Efavirenz / emtricitabine / tenofovir difumarate taken once a day or alternate day to Bictegravir / emtricitabine / tenofovir alafenamide in HIV+ patients with suppressed viral load. Passaggio da Efavirenz/emtricitabina/tenofovir difumarato assunto una volta al giorno o a giorni alterni a Bictegravir/emtricitabina/tenofovir alafenamide in pazienti HIV+ con carica virale soppressa. |
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| Not yet recruiting | 4 | 240 | Europe | Biktarvy, [-], Film-coated tablet, Biktarvy | ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI", Gilead Sciences Inc. | HIV infection Infezione da HIV, HIV infection infezione da HIV, Diseases [C] - Virus Diseases [C02] | | | | |
2017-005033-22: How does changing antiretroviral therapy effect the progression of coronary atherosclerosis. |
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| Not yet recruiting | 4 | 100 | Europe | Bictravy, EU/1/18//1289/001, Film-coated tablet, Bictravy | University of Liverpool, Gilead Pharmaceuticals, | Human immunodeficiency virus (HIV) and cardiovascular disease (CVD), Human immunodeficiency virus (HIV) and cardiovascular disease (CVD), Diseases [C] - Cardiovascular Diseases [C14] | | | | |
2018-004732-30: Will switching HIV-1-infected patients who have drug resistant HIV and stable on a regimen based on a protease inhibitor to another regimen based on the integrase inhibitor bictegravir be as equally effective? |
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| Not yet recruiting | 4 | 100 | Europe | Bictegravir, Tenofovir alafenamide fumarate, Emtricitabine, Tablet, Bictegravir, Tenofovir alafenamide fumarate, Emtricitabine | University of Sussex, Gilead Pharmaceuticals | Human Immunodeficiency Virus, HIV, Body processes [G] - Immune system processes [G12] | | | | |
2018-004499-36: study to assess the changes in bone health after changing from a TDF based regimen to Bicetegravir-Tenofovir Alafenamide-Emtricitavine based treatment Estudio para evaluar los cambios en la salud ósea tras el paso de un régimen basado en TDF a uno basado en Bictegravir-Tenofovir Alafenamida-Emtricitavina |
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| Not yet recruiting | 4 | 60 | Europe | Biktarvy, Stribild, EMEA/H/C/004449, Pastille, Tablet, Biktarvy, Atripla, Stribild, EVIPLERA, REZOLSTA, TRUVADA | Consorci Mar Parc de Salut de Barcelona, Consorci Mar Parc de Salut de Barcelona | Bone health (bone mineral density, microarchitecture and bone quality) in HIV individuals under antiretroviral treatment with tenofovir disoproxil fumarate (TDF) that change treatment to bictegravir-tenofovir alafenamide-emtricitavin (BIC) Salud ósea (densidad mineral ósea, microarquitectura y calidad ósea) en personas con VIH bajo tratamiento antirretroviral con tenofovir disoproxil fumarato (TDF) que cambia el tratamiento a bictegravir-tenofovir alafenamida-emtricitavina (BIC), bone health in persons with HIV treatment based on TDF that change the treatment to bictegravir-TAF salud ósea en personas con VIH y tratamiento antirretroviral con TDF que cambian el tratamiento a bictegravir-TAF, Diseases [C] - Virus Diseases [C02] | | | | |
2019-003614-14: Rapid ART Initiation with B/F/TAF in HIV people presenting with advanced HIV disease Rapido inizio di terapia ART con B/F/TAF nelle persone con HIV che si presentano con uno stadio di malattia da HIV avanzato |
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| Not yet recruiting | 4 | 30 | Europe | Biktarvy, [-], Film-coated tablet, Biktarvy | ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI", Gilead Sicences Inc. | HIV infection Infezione da HIV, HIV Infection Infezione da HIV, Diseases [C] - Virus Diseases [C02] | | | | |
2019-002843-81: Substitution current ARV therapy by BIKTARVY in hiv infected patients over 65 years old |
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| Not yet recruiting | 4 | 50 | Europe | Tablet, BIKTARVY | IMEA, IMEA | HIV-1-infected patientAge > 65 years oldPlasma HIV RNA ≤ 50 copies/mL for ≥ 6 months: one blip between 50 et 200 cp/ml is allowed in the last 6 months before screening.Currently receiving an antiretroviral regimen containing a booster, ritonavir or cobicistat No resistance mutation to integrase inhibitors on cumulative HIV RNA genotype. Patient enrolled in or a beneficiary of a Social Security program Informed consent form signed, Older up, 65HIV infection patientcuurently receving active ARVbeneficiary of a Social Securityand consent form signed, Diseases [C] - Virus Diseases [C02] | | | | |
2019-004109-28: HIV virus decrease in semen and rectum in patients HIV+ men, who starts treatment with dolutegravir plus lamivudine compared to Bictegravir/FTC/TAF Disminución del virus en semen y recto en pacientes hombres VIH+ que empiezan tratamiento con dolutegravir y lamivudina comparado con Bictegravir/FTC/TAF |
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| Ongoing | 4 | 24 | Europe | Tablet, TIVICAY, Lamivudine (generic drug), Biktarvy | Daniel Podzamczer Palter, IDIBELL | HIV infection Infección por el VIH, HIV infection Infección por el VIH, Diseases [C] - Immune System Diseases [C20] | | | | |
2020-000685-42: Virological and immunological assessment in HIV positive participants on 2DR versus 3DR in a prospective randomized controlled switch trial. Proef ter vergelijking van twee HIV behandelingen en hun effect op het virus, de weerstand en metabole gezondheid. |
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| Not yet recruiting | 4 | 134 | Europe | Biktarvy, Film-coated tablet, Dovato, Biktarvy | Ghent University Hospital, ViiV Healthcare, Ghent University Hospital | human immunodeficiency viruses (HIV), human immunodeficiency viruses (HIV), Diseases [C] - Virus Diseases [C02] | | | | |
| 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] | | | | |
2019-004871-38: Evaluation of the benefits of immediate versus conventional treatment with BIC / FTC / TAF in naive patients with type 1 HIV infection Evaluación de los beneficios del tratamiento inmediato versus convencional con BIC/FTC/TAF en pacientes naives con infección por VIH tipo 1 |
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| Not yet recruiting | 4 | 20 | Europe | Film-coated tablet, Biktarvy | FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE, INSTITUTO DE SALUD CARLOS III | HIV infection INFECCION POR VIH, HIV infection INFECCION POR VIH, Diseases [C] - Virus Diseases [C02] | | | | |
BIC-NOW, NCT06177574: Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: Clinical Trial |
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| Completed | 4 | 208 | Europe | BIC/FTC/TAF | Carmen Hidalgo Tenorio, Gilead Sciences | HIV Infections | 10/23 | 10/23 | | |
| Not yet recruiting | 4 | 200 | Europe | Biktarvy, Coated tablet, Biktarvy | Cliniques universitaires Saint-Luc, Fonds spécial de recherche; FNRS (pending) | HIV infection, HIV infection, Diseases [C] - Virus Diseases [C02] | | | | |
2020-003686-18: DTG/3TC vs. BIC/FTC/TAF maintenance therapy in people living with HIV: an open-label randomized clinical trial DTG / 3TC frente a BIC / FTC / TAF como terapia de mantenimiento en personas que viven con VIH: ensayo clínico abierto y aleatorizado |
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| Ongoing | 4 | 550 | Europe | Biktarvy, Dovato, Tablet, Biktarvy, Dovato | Seimc-Gesida Foundation, ViiV | HIV VIH, HIV VIH, Diseases [C] - Virus Diseases [C02] | | | | |
2021-004010-19: Pharmacokinetics of antirelease tratment in HIV-1 infected kidney transplant recipients after switch to biktarvy treatment: IMEA 064- KINETIK STUDY |
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| Not yet recruiting | 4 | | Europe | BIKTARVY, TAF/FTC/BIC, Tablet, BIKTARVY | IMEA-Fondation Léon M'Ba, IMEA-fondation Léon M'Ba | • HIV-1 infected patients > 18 years• Antiretroviral treatment switch to BIC/FTC/TAF decided in standard care by ID physician• Kidney transplant recipient ≥ 3 months• Receiving calcineurin and/or mTOR inhibitors without change in doses ≥ 4 weeks• Plasma HIV RNA ≤ 50 cpml ≥ 6 months (1 blip permitted 200cp/ml)• eGFR (CKD-EPI) ≥ 30 ml/mn/1.73m2• Written consent• GSS to BIC/FTC/TAF ≥ 2• Active contraception in potential child-bearing women, • HIV-1 infected patients • Antiretroviral treatment switch to BIC/FTC/TAF • Kidney transplant recipient • Receiving calcineurin and/or mTOR inhibitors • Written consent, Diseases [C] - Virus Diseases [C02] | | | | |
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 | | |
BICOLDER, NCT04222283: Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication |
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| Recruiting | 4 | 27 | Europe | BIKTARVY 50Mg-200Mg-25Mg Tablet | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba, Pierre and Marie Curie University | HIV Infections | 12/21 | 06/22 | | |
2021-005546-15: Simplified model using a mobile unit and a s test & treat approach among excluded population. Modelo simplificado que utiliza una unidad móvil y un enfoque de test and treat entre la población excluida. |
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| Not yet recruiting | 4 | 100 | Europe | BIKTARVY, EMEA/H/C/004449, Coated tablet, BIKTARVY | Gileas Science, Gilead Science | HIV AIDS VIH SIDA, HIV and AIDS VIH y SIDA, Diseases [C] - Virus Diseases [C02] | | | | |
2022-000358-26: Safety, tolerability, and efficacy of a dose reduction strategy based on bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed HIV-infected adults. Seguridad, tolerabilidad y eficacia de una estrategia de reducción de dosis basada en bictegravir /emtricitabina / tenofovir alafenamida en adultos infectados por el VIH con supresión viral |
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| Not yet recruiting | 4 | 40 | Europe | bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine, and tenofovir alafen, J05AR20, Coated tablet, Biktarvy 50 mg/200 mg/25 mg film-coated tablets | Institut d’Investigacions Biomèdiques August Pi i Sunyer, Instituto de Salud Carlos III (PI20/869) | HIV infection infección por HIV, HIV infection treatment tratamiento de Infecció por HIV, Diseases [C] - Virus Diseases [C02] | | | | |
2021-005927-19: Clinical trial designed to evaluate the safety and convenience of switching from Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir alafenamide in people with HIV, good control and neuropsychiatric vulnerabilities: MIND study Ensayo clínico para evaluar la seguridad y la conveniencia del cambio de Dolutegravir/Lamivudina por Bictegravir/Emtricitabina/Tenofovir alafenamida en personas con VIH, buen control y vulnerabilidades neuropsiquiátricas: Estudio MIND |
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| Not yet recruiting | 4 | 80 | Europe | Biktarvy, Dovato, EU/1/18/1289/004, EU/1/19/1370/002, Tablet, Biktarvy, DOVATO | Fundación SEIMC-GESIDA, Gilead Sciences S.A | Human immunodeficiency virus Virus de la inmunodeficiencia humana, Human immunodeficiency virus Virus de la inmunodeficiencia humana, Diseases [C] - Immune System Diseases [C20] | | | | |
NCT04311957: Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults |
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| Not yet recruiting | 4 | 386 | RoW | Continuation of boosted PI, B/F/TAF | Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Brigham and Women's Hospital, Harvard Medical School, Analysis Group, Inc., Weill Medical College of Cornell University | HIV-1-infection, Antiretroviral Therapy | 05/22 | 11/22 | | |
ChiCTR2100048080: Safety and Tolerability of Biktarvy Following Potential Exposure to HIV-1 |
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| Not yet recruiting | 4 | 100 | | Taking Biktarvy | Beijing Youan Hospital, Capital Medical University; Beijing Youan Hospital, Capital Medical University, Gilead Sciences, Inc | HIV infection | | | | |
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 | 134 | Europe | Dual versus triple therapy in treatment of HIV-1 infection., not applicatble | University Hospital, Ghent, ViiV Healthcare | HIV-1-infection | 06/26 | 04/27 | | |
| Completed | 4 | 28 | US | B/F/TAF, Bictegravir/emtricitabine/tenofovir alafenamide | University of Maryland, Baltimore, Gilead Sciences | HIV-1-infection, Hepatitis B | 11/22 | 05/23 | | |
NCT05147740: Study to Assess Switching to B/F/TAF in Treatment Experienced People With HIV Who Are at Least 65 Years of Age |
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| Recruiting | 4 | 50 | US | B/F/TAF, Biktarvy® | Tulika Singh, MD, Gilead Sciences | HIV-1-infection | 12/22 | 12/22 | | |
NCT04296695: Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection |
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| Active, not recruiting | 4 | 250 | RoW | B/F/TAF, Biktarvy, TDF/3TC/EFV, Tenofovir /Ravmidine /Efavirenz | Peking Union Medical College Hospital, Gilead Sciences | HIV-1-infection | 12/22 | 12/23 | | |
NCT05122754: Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 Infection |
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| Active, not recruiting | 4 | 150 | RoW | B/F/TAF, TDF-based triple ART regimen switching to B/F/TAF | Shanghai Public Health Clinical Center, Xixi Hospital of Hangzhou, Yunnan AIDS Care Center | HIV-1-infection | 02/24 | 04/24 | | |
| Completed | 4 | 520 | RoW | Switch to B/F/TAF, Biktarvy, Continue current regimen, Control | University of Nairobi, Gilead Sciences | HIV-1-infection | 04/23 | 03/24 | | |
| Terminated | 4 | 1 | Europe | BIKTARVY 50Mg-200Mg-25Mg Tablet | Chelsea and Westminster NHS Foundation Trust, Gilead Sciences, Imperial College London | Human Immunodeficiency Virus | 05/23 | 05/23 | | |
2020-001070-29: Efficacy, tolerability and acceptability of the single tablet regimen (STR) Biktarvy® by trans people living with HIV (TPLWH) Eficacia, tolerabilidad y aceptabilidad de régimen de un comprimido diario (STR) Biktarvy® en personas trans con VIH |
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| Not yet recruiting | 4 | 50 | Europe | Biktarvy, Film-coated tablet, Biktarvy | Chelsea and Westminster NHS Foundation Trust, Gilead Sciences Inc. | Human Immunodeficiency Virus (HIV) infection Infección por el virus de la inmunodeficiencia humana (VIH), Human Immunodeficiency Virus (HIV) infection Infección por el virus de la inmunodeficiencia humana (VIH), Diseases [C] - Virus Diseases [C02] | | | | |
| Active, not recruiting | 4 | 40 | US | Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg, Biktarvy | University of Southern California | Acute HIV Infection | 06/23 | 06/23 | | |
KINETIK, NCT04993872: Pharmacokinetics of Calcineurin & mTOR Inhibitors in HIV-1 Infected Kidney Transplant Recipients After Switch to BIC/FTC/TAF |
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| Active, not recruiting | 4 | 5 | Europe | Biktarvy Tab | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba, LAMBERT ASSOUMOU/ UNITE 1136 INSERM, Sebastien GALLIEN/Henri Mondor University Hospital- Infectiology Department, THOMAS STEHL/ HENRI MONDOR HOSPITAL-Department of Nephrology | HIV-infected Patient Kidney Transplant Recipient | 07/23 | 07/24 | | |
DYAD, NCT04585737: Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF |
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| Completed | 4 | 222 | US | Dolutegravir / Lamivudine Pill, Dovato, Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill, Biktarvy | Charlotte-Paige Rolle, MD, ViiV Healthcare | HIV I Infection | 08/23 | 08/23 | | |
| Terminated | 4 | 10 | US | bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), Biktarvy, Standard initiation of antiretroviral therapy (ART), Standard of Care ART | University of Colorado, Denver, Gilead Sciences | HIV/AIDS | 07/23 | 07/23 | | |
| Active, not recruiting | 4 | 45 | Canada | Biktarvy 50/200/25 Tab, Estradiol Tablets, Oral 17(beta)-estradiol | Maple Leaf Research | Hiv, Transgenderism | 11/24 | 01/25 | | |
| Active, not recruiting | 4 | 40 | US | Dolutegravir/Lamivudine, Dovato | Saint Michael's Medical Center, ViiV Healthcare | Human Immunodeficiency Virus | 10/23 | 12/23 | | |
SIMPLIFIED, NCT05405751: Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. |
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| Completed | 4 | 100 | Europe | Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY] | Fundacion SEIMC-GESIDA | HIV Infections | 12/23 | 06/24 | | |
NCT04530630: Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant |
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| Completed | 4 | 20 | US | BIKTARVY 50Mg-200Mg-25Mg Tablet | Weill Medical College of Cornell University, Gilead Sciences | HIV Infections, Renal Transplant Rejection | 08/24 | 08/24 | | |
ChiCTR2100042380: Post-Authorization Study to Evaluate the Safety and Effectiveness of Biktarvy in Patients with Human Immunodeficiency Virus-1(HIV-1) infection in China |
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| Completed | 4 | 3000 | | Nil | Guangzhou Eighth People's Hospital / Beijing Ditan Hospital Capital Medical University; Gilead Sciences Shanghai Pharmaceutical Technology., Ltd, Gilead Sciences Shanghai Parmaceutical Technology Co.,Ltd. | HIV-1 | | | | |
NCT04650269: Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program |
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| Completed | 4 | 27 | US | Biktarvy 50Mg-200Mg-25Mg Tablet, HIV care | University of Miami, Gilead Sciences | Harm Reduction, HIV Infections, Drug Use | 12/23 | 12/23 | | |
ChiCTR2200059030: The efficacy and safety of B/F/TAF tablets replacing stable antiretroviral therapy in adolescents living with HIV-1 |
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| Not yet recruiting | 4 | 240 | | Swith to BIC/F/TAF ;NA | Beijing Ditan Hospital, Capital Medical University; Beijing Ditan Hospital, Capital Medical University, In-house subject | AIDS | | | | |
| Recruiting | 4 | 330 | RoW | B/F/TAF, Biktarvy®), TDF/3TC/EFV or DTG or NVP, DMPA, Depo-provera | MU-JHU CARE | Bone Loss | 03/24 | 03/24 | | |
| Recruiting | 4 | 120 | US | The Accelerate model of care, bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg | University of Missouri-Columbia, Gilead Sciences | HIV Infections, ART, Noncompliance, Patient | 05/25 | 11/25 | | |
NCT06375304: The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study |
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| Not yet recruiting | 4 | 50 | Canada | B/F/TAF | McGill University Health Centre/Research Institute of the McGill University Health Centre | HIV Infections | 06/26 | 05/27 | | |
ChiCTR2200063461: Clinical study of switching to Bictegravir/emtricitabine/tenofovir alafenamide single-tablet therapy in HIV-infected patients with viral suppression and historical drug resistance mutations |
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| Not yet recruiting | 4 | 200 | | Bicarbonate propionol tablets | Infectious of Department, Nanjing Second Hospital; Nanjing Second Hospital, self-funded | AIDS | | | | |
NCT06337032: A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments |
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| Recruiting | 4 | 350 | RoW | F/TAF (High Dose Tablet), Descovy®, F/TAF (Low Dose Tablet), F/TAF (Lowest Dose Tablet), F/TAF (High Dose TOS), F/TAF (Low Dose TOS), F/TAF (Lowest Dose TOS), E/C/F/TAF, Genvoya®, E/C/F/TAF (Low Dose), Cobicistat (High Dose), GS-9350, Tybost®, Cobicistat (Low Dose), Cobicistat (TOS), B/F/TAF (High Dose), Biktarvy®, GS-9883/F/TAF, B/F/TAF (Low Dose), B/F/TAF (High Dose TOS), B/F/TAF (Low Dose TOS), B/F/TAF (Lowest Dose TOS), 3rd ARV Agent, Nucleos(t)ide reverse transcriptase inhibitors (NRTI), ATV, DRV, Lopinavir Boosted with ritonavir (LPV/r) | Gilead Sciences | HIV-1-infection | 03/34 | 03/34 | | |
| 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 | | |
NCT06104306: Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER) |
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| Active, not recruiting | 4 | 33 | Europe, Canada, US | B/F/TAF, Biktarvy ® | Gilead Sciences | HIV-1-infection | 02/25 | 05/25 | | |
BETAF-RED, NCT05602506: Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults |
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| Active, not recruiting | 4 | 40 | Europe | Biktarvy 50 mg/200 mg/25 mg film-coated tablets | Fundacion Clinic per a la Recerca Biomédica | HIV Infections | 11/24 | 07/25 | | |
| Active, not recruiting | 4 | 555 | Europe | Dolutegravir/Lamivudine as a single pill, Bictegravir/Emtricitabine/Tenofovir alfenamide as a single pill. | Fundacion SEIMC-GESIDA, ViiV Healthcare | HIV-1-infection | 02/24 | 02/25 | | |
MIND, NCT05549180: Phase IV, a Clinical Trial to Assess Safety and Convenience of the Change From DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control and Neuropsychiatric Vulnerabilities |
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| Completed | 4 | 84 | Europe | BIKTARVY 50Mg-200Mg-25Mg Tablet and Dovato placebo, Dovato 50Mg-300Mg Tablet + Biktarvy placebo | Fundacion SEIMC-GESIDA | HIV Infections | 02/24 | 08/24 | | |
NCT05463783: Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain |
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| Recruiting | 4 | 30 | US | Biktarvy, bictegravir/emtricitabine/tenofovir alafenamide, Symtuza, darunavir/cobicistat/emtricitabine/tenofovir alafenamide | East Carolina University, Janssen Scientific Affairs, LLC | HIV Infections, Obesity | 03/25 | 03/25 | | |
ChiCTR2400082475: Efficacy and effects on metabolic markers of switching to ANV/3TC/TDF single-tablet regimen versus switching to BIC/FTC/TAF regimen in suppressed treatment-experienced HIV-1 infected patients: Week 48 Results of multi-center, randomized Clinical trial |
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| Not yet recruiting | 4 | 462 | | Switch to ANV/3TC/TDF; Switch to BIC/FTC/TAF | The Sixth People's Hospital of Zhengzhou; The Sixth People's Hospital of Zhengzhou, Jiangsu Aidea pharmaceutical Co.,Ltd. | HIV-1 infection | | | | |
ChiCTR2400080553: Clinical study of BIC/FTC/TAF and EFV+TDF+3TC for rapid initiation of antiviral therapy in HIV-1 patients |
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| Not yet recruiting | 4 | 80 | | Buccanol tablets (BIC/FTC/TAF); EFV+TDF+3TC | Chest Hospital of Guangxi Zhuang Autonomous Region; Chest Hospital of Guangxi Zhuang Autonomous Region, Clinical study of BIC/FTC/TAF and EFV+TDF+3TC for rapid initiation of antiviral therapy in HIV-1 pat | HIV-1 first treatment patients，Can be asymptomatic or symptomatic patients. Commonly associated opportunistic infections include oral candidiasis, Marneffei's cyanobacteriosis, pulmonary tuberculosis, and Yersinia pneumoniae pneumonia. | | | | |
2018-002310-12: Bictegravir concentrations and antiviral activity in genital fluids and rectal compartment in HIV-1 infected individuals (“BIGER Study”). Concentraciones de bictegravir y actividad antiviral en fluidos genitales y compartimento rectal en individuos infectados con VIH-1 ("Estudio BIGER"). |
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| Ongoing | 3 | 23 | Europe | Bictegravir, emtricitabine, tenofovir alafenamide, J05AR20, Tablet | Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA | HIV-1 infected male and female adults not previously exposed to ART. Hombres y mujeres adultos infectados con VIH-1 no expuestos previamente a TAR., HIV-1 infected male and female adults not previously exposed to ART. Hombres y mujeres adultos infectados con VIH-1 no expuestos previamente a TAR., Diseases [C] - Virus Diseases [C02] | | | | |
2018-003481-13: An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV Disease -The Late Presenter Treatment Optimisation Study (LAPTOP)- |
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| Not yet recruiting | 3 | 440 | Europe | Biktarvy, Symtuza, [J05AR], [J05AR22], Film-coated tablet, Biktarvy, Symtuza | NEAT ID Foundation, Gilead Sciences Inc, Janssen Pharmaceutica NV, Gilead Sciences, Inc., | Patients who present late on during their acquisition of the HIV-1 (Human Immunodeficiency Virus), A virus that damages patient's immune system causing the patient difficulty to fight off infections and diseases., Diseases [C] - Virus Diseases [C02] | | | | |
2019-000812-27: Initiation of first-line antiretroviral treatment with TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the first clinical contact in France: Trial IMEA 055 – FAST Instauration immédiate, dès le 1er contact médical, d’un traitement antirétroviral par TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR : ESSAI IMEA 055 - FAST |
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| Not yet recruiting | 3 | 110 | Europe | Tablet, BIKTARVY | IMEA, IMEA | HIV positiveage > 18 years- newly diagnosed HIV-infected individual evidenced by any tests- antiretroviral-treatment naive - negative urine pregnancy test - willing to sign an informed written consent– - regular health insurance - willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7, - adult patients (>18 years )newly diagnosed HIV-infected, antiretroviral-treatment naive ,- no pregnancy and compliant, Diseases [C] - Virus Diseases [C02] | | | | |
2019-001961-34: ANRS 173 ALTAR (ALlégement du Traitement AntiRétroviral) ANRS 173 ALTAR (ALlégement du Traitement AntiRétroviral) |
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| 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] | | | | |
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 |
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| 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] | | | | |
MK-8591A-018, NCT04223791 / 2019-000587-23: Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) |
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| Active, not recruiting | 3 | 643 | Europe, Canada, Japan, US, RoW | DOR/ISL, MK-8591A, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to FDC DOR/ISL, Placebo to MK-8591A | Merck Sharp & Dohme LLC | HIV Infection | 08/21 | 02/25 | | |
NCT03656783: Effects of Biktarvy on CFR in Stable HIV Patients |
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| Completed | 3 | 25 | US | Biktarvy, Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) | Brigham and Women's Hospital, Tufts Medical Center, Boston Medical Center | HIV | 09/21 | 09/21 | | |
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 | | |
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 |
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| 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 | | |
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] | | | | |
MK-8591A-020, NCT04233879 / 2019-000590-23: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection |
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| Active, not recruiting | 3 | 599 | Europe, Canada, Japan, US, RoW | DOR/ISL, MK-8591A, Doravirine/islatravir, BIC/FTC/TAF, Bictegravir/emtricitabine/tenofovir alafenamide, Placebo to BIC/FTC/TAF, Placebo to DOR/ISL | Merck Sharp & Dohme LLC | HIV-1 Infection | 11/22 | 03/25 | | |
| Withdrawn | 3 | 150 | US | DOR/3TC/TDF, Delstrigo, DOR + FTC/TAF, Pifeltro + Descovy, BIC/FTC/TAF, Biktarvy | Prism Health North Texas, Merck Sharp & Dohme LLC | Body Weight Changes, Human Immunodeficiency Virus, ART, Obesity, Minority Health, BMD, Metabolic Syndrome, Fasting | 05/23 | 05/23 | | |
NCT04416906: A Test and Treat Strategy in New HIV Diagnosis. |
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| Completed | 3 | 100 | Europe | Biktarvy | Judit Pich Martínez, Gilead Sciences | HIV-1-infection | 05/23 | 05/23 | | |
| Completed | 3 | 36 | Europe | Biktarvy, Symtuza | Chelsea and Westminster NHS Foundation Trust, Imperial College London, Gilead Sciences | Human Immunodeficiency Virus | 07/23 | 07/23 | | |
| 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 | | |
ARTISTRY-2, NCT06333808: Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy |
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| Active, not recruiting | 3 | 577 | Europe, Canada, Japan, US, RoW | Bictegravir, GS-9883, Lenacapavir, GS-6207, B/F/TAF, Biktarvy ®, Placebo to match B/F/TAF, Placebo to match BIC/LEN | Gilead Sciences | HIV-1-infection | 12/25 | 12/29 | | |
| Completed | 3 | 15 | US | Next-generation Reader and ID-Cap System, Digital pill system, Truvada for pre-exposure prophylaxis (PrEP), Biktarvy for antiretroviral therapy (ART) | Brigham and Women's Hospital, The Fenway Institute | HIV Infection, Adherence, Medication, Adherence, Treatment, Pre-Exposure Prophylaxis, Antiretroviral Therapy | 07/24 | 07/24 | | |
| Completed | 3 | 447 | Europe | Biktarvy, Symtuza | NEAT ID Foundation, Gilead Sciences, Janssen Pharmaceuticals | HIV/AIDS | 06/24 | 06/24 | | |
| Active, not recruiting | 3 | 240 | RoW | DTG/3TC, Avridela | University of Nairobi, ViiV Healthcare | HIV-1-infection | 07/25 | 07/26 | | |
ISLEND-2, NCT06630299: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 |
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| Recruiting | 3 | 600 | Japan, US, RoW | ISL/LEN, Antiretroviral Combinations | Gilead Sciences | HIV-1-Infection | 06/27 | 08/30 | | |
ISLEND-1, NCT06630286: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 |
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| Recruiting | 3 | 600 | Europe, Canada, Japan, US, RoW | ISL/LEN, B/F/TAF, Biktarvy®, PTM B/F/TAF, PTM ISL/LEN | Gilead Sciences | HIV-1-infection | 06/26 | 08/30 | | |
MK-8591A-052, NCT05630755: A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) |
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| Active, not recruiting | 3 | 514 | Europe, Japan, US, RoW | DOR/ISL, MK-8591A, Doravirine/Islatravir, BIC/FTC/TAF, Bictegravir/Emtricitabine/Tenofovir Alafenamide, Placebo to BIC/FTC/TAF, Placebo to DOR/ISL | Merck Sharp & Dohme LLC | HIV-1 Infection | 10/24 | 08/28 | | |
EYEWITNESS, NCT05911360: A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF |
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| Active, not recruiting | 3 | 206 | Europe, Canada, US, RoW | DTG/3TC | ViiV Healthcare | HIV, HIV Infections | 02/25 | 02/26 | | |
VOGUE, NCT05979311: A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy |
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| Recruiting | 3 | 412 | Europe, Japan, RoW | Dolutegravir, Lamivudine, Bictegravir, Emtricitabine, Tenofovir alafenamide | ViiV Healthcare | HIV, HIV Infections | 11/25 | 10/26 | | |
NCT05705349: DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053) |
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| Active, not recruiting | 3 | 500 | Europe, Canada, Japan, US, RoW | DOR/ISL, MK-8591A, BIC/FTC/TAF, Placebo to DOR/ISL, Placebo to BIC/FTC/TAF | Merck Sharp & Dohme LLC | HIV-1 Infection | 10/25 | 08/29 | | |
NCT02881320 / 2016-002345-39: Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 |
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| Active, not recruiting | 2/3 | 177 | US, RoW | B/F/TAF (Adult Strength), Biktarvy®, GS-9883/F/TAF, B/F/TAF (Low Dose), B/F/TAF (TOS) | Gilead Sciences | HIV-1 Infection | 03/25 | 09/25 | | |
NCT06544733: Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed |
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| Active, not recruiting | 2/3 | 675 | US | GS-1720, GS-4182, Placebo to Match BVY, Bictegravir/emtricitabine/tenofovir alafenamide, Biktarvy®, GS-1720/GS-4182 FDC, Placebo to Match GS1720/GS-4182 FDC | Gilead Sciences | HIV-1-Infection | 01/28 | 06/29 | | |
NCT06613685: Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated |
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| Recruiting | 2/3 | 675 | Canada, US | GS-1720, GS-4182, Bictegravir/emtricitabine/tenofovir alafenamide, Biktarvy ®, GS-1720/GS-4182 FDC, Placebo to Match BVY, Placebo to Match GS1720/GS-4182 FDC | Gilead Sciences | HIV-1-infection | 01/29 | 08/30 | | |
NCT02859558: Early ART to Limit Infection and Establishment of Reservoir |
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| Active, not recruiting | 2 | 195 | US, RoW | elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy, Single-tablet regimen EVG/COBI/FTC/TAF or Genvoya, Single-tablet regimen BIC/FTC/TAF or Biktarvy | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, National Institute of Allergy and Infectious Diseases (NIAID) | HIV-1 Infection | 12/20 | 04/25 | | |
| Not yet recruiting | 2 | 140 | Europe | Islatravir, MK-8507, MK-8591, MK-8507, Capsule, Tablet, Film-coated tablet, Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc | HIV-1 infection, HIV-1 infection, Diseases [C] - Virus Diseases [C02] | | | | |
CALIBRATE, NCT04143594: Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV |
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| Completed | 2 | 183 | US, RoW | Oral Lenacapavir, GS-6207, F/TAF, Descovy®, Subcutaneous Lenacapavir, TAF, BIC, B/F/TAF, Biktarvy® | Gilead Sciences | HIV-1-infection | 10/21 | 09/23 | | |
| Recruiting | 2 | 66 | Europe | 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide, Biktarvy | Anna Cruceta | HIV Primary Infection | 11/22 | 06/23 | | |
| Recruiting | 2 | 434 | Canada | nPEP, Biktarvy, Bictegravir/emtricitabine/tenofovir alafenamide, BIC/FTC/TAF, Text Messaging Support, Nurse-Led nPEP | Unity Health Toronto, Canadian Institutes of Health Research (CIHR), CIHR Canadian HIV Trials Network | HIV Infections | 12/22 | 08/23 | | |
MK-8591-013, NCT04564547: Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [] |
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| Active, not recruiting | 2 | 161 | Europe, US | Islatravir, MK-8591, Ulonivirine, MK-8507, BIC/FTC/TAF, BIKTARVY®, Placebo to ISL, Placebo to Ulonivirine, Placebo to BIC/FTC/TAF | Merck Sharp & Dohme LLC | HIV-1 Infection | 01/25 | 01/25 | | |
NCT05052996: Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV |
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| Active, not recruiting | 2 | 142 | US | ISL, LEN, GS-6207, B/F/TAF, Biktarvy® | Gilead Sciences, Merck Sharp & Dohme LLC | HIV-1 Infection | 12/23 | 11/27 | | |
| Active, not recruiting | 2 | 122 | RoW | Biktarvy®, TLD- fixed-drug combination single tablet, Dolutegravir 50mg /Lamivudine 300mg/ Tenofovir 300mg | Centre for the AIDS Programme of Research in South Africa, Johns Hopkins University, National Institute of Allergy and Infectious Diseases (NIAID), University of Cape Town, Medical Research Council, South Africa | HIV/AIDS, Tuberculosis, Pulmonary | 01/24 | 08/24 | | |
NCT05719441: A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission |
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| Recruiting | 2 | 48 | US, RoW | VRC07-523LS, VRC-HIVMAB075-00-AB, PGT121.414.LS, VRC-HIVMAB0107-00-AB, Placebo, ART, Biktarvy | National Institute of Allergy and Infectious Diseases (NIAID) | Acute HIV Infection | 04/28 | 09/28 | | |
2021-000436-62: This study will evaluate the relative bioavailability of the B/F/TAF tablet for oral suspension formulation compared to the adult-strength B/F/TAF tablet and will inform on appropriateness of this formulation for future clinical studies in children with HIV. |
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| Not yet recruiting | 1 | 198 | US | Biktarvy, Emtricitabine/Tenofovir Alafenamide, B/F/TAF, F/TAF, Film-coated tablet, Tablet, Biktarvy | Gilead Sciences, Inc, Gilead Sciences, Inc | Human Immunodeficiency Virus (HIV-1) Infection, Human Immunodeficiency Virus (HIV-1) Infection, Diseases [C] - Virus Diseases [C02] | | | | |
NCT04950530: The Effect of Biktarvy (B/F/TAF) on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers |
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| Completed | 1 | 25 | Europe | BIKTARVY 50Mg-200Mg-25Mg Tablet, BIC/FTC/TAF, Bictegravir | Chelsea and Westminster NHS Foundation Trust | HIV-1-infection | 02/24 | 02/24 | | |
NCT06356194: Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir |
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| Completed | 1 | 28 | Canada | Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIK, Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. | Atea Pharmaceuticals, Inc. | Healthy Volunteer Study | 05/24 | 05/24 | | |
NCT05585307: Study of Novel Antiretrovirals in Participants With HIV-1 |
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| Completed | 1 | 49 | US, RoW | bavtavirine, GS-5894, B/F/TAF, Biktarvy®, Standard of Care (Substudy 01), GS-1720, Standard of Care (Substudy 02), GS-6212, Standard of Care (Substudy 03) | Gilead Sciences | HIV-1-infection | 02/24 | 03/24 | | |
NCT06518213: Efficacy and Safety of First-line ART With BIC/FTC/TAF Introduced at the First Clinical Visit |
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| Completed | N/A | 112 | RoW | | University Hospital for Infectious Diseases, Croatia | HIV Infections | 12/22 | 03/24 | | |
BICFOTO, NCT06773754: Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Taken as 5 Days Per Week |
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| Active, not recruiting | N/A | 60 | RoW | Five-days-On and Two-days-Off | National Taiwan University Hospital | Virally Suppressed People With HIV | 09/23 | 12/25 | | |
| Recruiting | N/A | 200 | RoW | Bictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet [Biktarvy] | National Taiwan University Hospital, Far Eastern Memorial Hospital, Mackay Memorial Hospital, Changhua Christian Hospital, Chung Shan Medical University, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Municipal Ta-Tung Hospital | HIV Infections | 12/22 | 01/23 | | |
ChiCTR2200059994: A clinical research for Biktarvy following potential exposure to HIV-1 |
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| Not yet recruiting | N/A | 100 | | Biktarvy is taken orally once a day. ;TDF+FTC+DTG/RAL | Guiyang public health treatment center; Guiyang public health treatment center, self-finacing | HIV/AIDS | | | | |
NCT05064020: Bictegravir in the Elderly Living With HIV (BICEP) |
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| Active, not recruiting | N/A | 162 | US | Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY], Biktarvy, BIC/FTC/TAF | State University of New York at Buffalo, Gilead Sciences | HIV-1-infection | 12/24 | 12/24 | | |
