6 completed, 1 active not recruiting, 1 recruiting, 1 terminated. 10 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 10 | Completed 6, Active not recruiting 1, Recruiting 1, Terminated 1, Unknown 1 |
Follow bictegravir: new trials by email Literature Review of bictegravir trials Research Report on bictegravir
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) Bictegravir 50 MG / Emtricitabine 200 MG / Tenofovir Alafenamide 25 MG [Biktarvy], dolutegravir 50 mg / lamivudine 300 mg - HIV Infections | Phase 4 | Completed | Cristina Mussini | 66 | 2020-01-23 | 2026-05-01 |
| Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch - HIV-1-infection | Phase 4 | Completed | Quest Clinical Research | 20 | 2019-12-19 | 2024-03-05 |
| Empiric Treatment for Acute HIV in the ED Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg - Acute HIV Infection | Phase 4 | Unknown | University of Southern California | 40 | 2019-10-14 | 2023-04-26 |
| Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP) bictegravir - HIV Prevention | Phase 4 | Completed | Fenway Community Health | 52 | 2019-01-24 | 2022-04-07 |
HIV Infections (4) · Acquired Immunodeficiency Syndrome (1) · Emergencies (1) · Metabolic Syndrome (1) · Patient Compliance (1)
Fundacion SEIMC-GESIDA (2) · Charlotte-Paige Rolle, MD (1) · Cristina Mussini (1) · Fenway Community Health (1) · Instituto Mexicano del Seguro Social (1) · Quest Clinical Research (1) · University of Colorado, Denver (1) · University of Missouri-Columbia (1) · University of Southern California (1)
United States (6) · Spain (2) · Italy (1) · Mexico (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)
PMID 34991141, PMID 37908359, PMID 40489982
2018 (1)