15 completed, 5 active not recruiting, 4 unknown, 2 not yet recruiting. 10 Phase 4, 6 Phase 3, 4 Phase 1, 4 Phase 2, 2 Not applicable.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study on Retention in Care and on Clinical Chracteristics of HIV-infected Women Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIKWO). Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) - HIV 1 Infection | Not yet recruiting | Ente Ospedaliero Ospedali Galliera | 100 | 2026-12-15 | 2026-10-09 | |
| Research on the Psychological Status of Patients With HIV-1 Infection All kinds of INSTI medications, All kinds of conventional medications - HIV-1-infection, Anxiety Depression | Not yet recruiting | Shanxi Bethune Hospital | 500 | 2025-08-01 | 2025-07-23 | |
| Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience DTG/3TC, Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) - HIV Infection, Metabolic Syndrome | Phase 4 | Recruiting | Instituto Mexicano del Seguro Social | 124 | 2025-04-01 | 2025-06-26 |
| Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 Lenacapavir, Bictegravir/Lenacapavir (BIC/LEN) FDC, Bictegravir/Lenacapavir - HIV-1-infection | Phase 2 / Phase 3 | Active not recruiting | Gilead Sciences | 75 | 2024-11-20 | 2026-09-29 |
| Accelerated ART Initiation for PWHIV Who Are Out of Care The Accelerate model of care, bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg - HIV Infections, ART | Phase 4 | Active not recruiting | University of Missouri-Columbia | 120 | 2024-04-29 | 2026-08-05 |
| Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy Bictegravir, Lenacapavir, B/F/TAF - HIV-1-infection | Phase 3 | Active not recruiting | Gilead Sciences | 577 | 2024-03-25 | 2026-06-15 |
| 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 Dolutegravir, Lamivudine, Bictegravir - HIV, HIV Infections | Phase 3 | Active not recruiting | ViiV Healthcare | 463 | 2024-02-21 | 2026-10-14 |
| The Effect of Biktarvy (B/F/TAF) on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers BIKTARVY 50Mg-200Mg-25Mg Tablet - HIV-1-infection | Phase 1 | Completed | Chelsea and Westminster NHS Foundation Trust | 25 | 2022-12-22 | 2024-12-10 |
| Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1) Bictegravir, Lenacapavir, BIC/LEN FDC - HIV-1-infection | Phase 2 / Phase 3 | Active not recruiting | Gilead Sciences | 689 | 2022-08-16 | 2026-10-21 |
| Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (SIMPLIFIED) Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY] - HIV Infections | Phase 4 | Completed | Fundacion SEIMC-GESIDA | 101 | 2022-07-04 | 2026-06-30 |
| Rapid Antiretroviral Treatment Initiation With BIC/FTC/TAF in HIV-infected People Who Inject Drugs (PWID) bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) - HIV Positive People Who Inject Drugs | Completed | Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases | 37 | 2021-12-22 | 2025-06-04 | |
| Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum Bictegravir (BIC), Tenofovir alafenamide (TAF), Long-acting injectable formulation of cabotegravir (CAB LA) - HIV, Tuberculosis | Terminated | National Institute of Allergy and Infectious Diseases (NIAID) | 205 | 2021-09-01 | 2026-08-26 | |
| DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: Dolutegravir/Lamivudine as a single pill, Bictegravir/Emtricitabine/Tenofovir alfenamide as a single pill. - HIV-1-infection | Phase 4 | Completed | Fundacion SEIMC-GESIDA | 554 | 2021-07-14 | 2025-07-18 |
| Incidence of Metabolic Syndrome in People Living With HIV Without ExperienCe to ART Who Start DoLutegravir Based-Regimen Compared With BictegrAvir Based-RegimeN Bictegravir - Antiretroviral Treatment, HIV Infection | Not applicable | Completed | Instituto Mexicano del Seguro Social | 378 | 2021-06-25 | 2024-10-08 |
| A Study of JNJ-56136379 in Healthy Participants JNJ-56136379, Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF) - Healthy | Phase 1 | Withdrawn | Janssen Research & Development, LLC | 2021-05-06 | 2021-07-15 | |
| Gut Microbiota, PGx and INSTIs Response Dolutegravir, Bictegravir - HIV Infections | Completed | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | 180 | 2021-03-10 | 2024-05-10 | |
| Same-day Antiretroviral Therapy With BIC/F/TAF Bictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet [Biktarvy] - HIV Infections | Not applicable | Unknown | National Taiwan University Hospital | 200 | 2021-01-20 | 2021-01-19 |
| Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), Standard initiation of antiretroviral therapy (ART) - HIV/AIDS | Phase 4 | Terminated | University of Colorado, Denver | 10 | 2020-12-15 | 2023-11-30 |
| Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide - HIV Primary Infection | Phase 2 | Unknown | Anna Cruceta | 66 | 2020-12-04 | 2021-07-19 |
| Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF Dolutegravir / Lamivudine Pill, Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill - HIV I Infection | Phase 4 | Completed | Charlotte-Paige Rolle, MD | 222 | 2020-10-05 | 2024-10-17 |
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HIV Infections (8) · Acquired Immunodeficiency Syndrome (5) · Metabolic Syndrome (2) · Dyslipidemias (1) · Emergencies (1) · Insulin Resistance (1) · Patient Compliance (1) · Tuberculosis (1) · Weight Gain (1)
Gilead Sciences (7) · Fundacion SEIMC-GESIDA (2) · Instituto Mexicano del Seguro Social (2) · Anna Cruceta (1) · Brigham and Women's Hospital (1) · Charlotte-Paige Rolle, MD (1) · Chelsea and Westminster NHS Foundation Trust (1) · Cliniques universitaires Saint-Luc- Université Catholique de Louvain (1) · Cristina Mussini (1) · Ente Ospedaliero Ospedali Galliera (1) · Fenway Community Health (1) · Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases (1) · Janssen Research & Development, LLC (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · National Taiwan University Hospital (1)
United States (16) · Spain (8) · Italy (7) · United Kingdom (5) · Argentina (4) · Germany (4) · Mexico (4) · Puerto Rico (4) · Australia (3) · Belgium (3) · Canada (3) · France (3) · Japan (3) · South Africa (3) · Taiwan (3)
Ana Milinkovic (1) · Charlotte-Paige Rolle, MD (1) · Dima Dandachi, MD, MPH (1) · Esteban Martinez, MD (1) · Hillary Dunlevy, MD (1) · Kathleen Jacobson, MD (1) · Kenneth H Mayer, MD (1) · Marcelo Di Carli, MD (1) · Mark Mirochnick, MD (1) · Mina Psichogiou, Professor (1) · Qing Ma, PharmD, PhD (1)
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