Biktarvy 50 mg/200 mg/25 mg film-coated tablets
Sponsors
Merck Sharp & Dohme LLC, Viiv Healthcare UK Limited, Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La C, NEAT ID Foundation, Gilead Sciences Inc.
Conditions
HIVHIV InfectionsHIV-1 InfectionHIV-1 infectionHIV-infectedHuman Immunodeficiency VirusHuman immunodeficiency virus (HIV)Patients who present late on during their acquisition of the HIV-1
(Human Immunodeficiency Virus)
Phase 2
An Operationally Seamless Phase 2/3, Randomized, Active Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination with GS-4182 Versus Biktarvy in Treatment Naive People with HIV-1
SuspendedCTIS2024-512505-66-00
Start: 2025-03-03Target: 186Updated: 2025-10-29
An Operationally Seamless Phase 2/3, Randomized, Active -Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1
Not yet recruitingCTIS2024-511054-50-00
Target: 35Updated: 2025-04-02
Phase 3
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
WithdrawnCTIS2022-502099-22-00
Target: 124Updated: 2023-05-02
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
WithdrawnCTIS2022-502079-49-00
Target: 180Updated: 2023-05-02
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)-
CompletedCTIS2023-505167-36-00
Start: 2019-08-05End: 2024-06-17Target: 357Updated: 2024-04-08
A Phase 3b, multicenter, single-arm, open-label study evaluating the efficacy, safety, and tolerability of switching to DTG/3TC single tablet regimen administered once daily from a bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in people living with HIV of at least 50 years of age who are virologically suppressed
Active, not recruitingCTIS2022-503137-66-00
Start: 2023-11-29Target: 117Updated: 2025-11-23
A Phase 3b, multi-center, randomized, parallel-group, open-label, non-inferiority study evaluating the efficacy, safety, and tolerability of oral dolutegravir/lamivudine once-daily as a first-line regimen compared to oral bictegravir/emtricitabine/tenofovir alafenamide once daily for virologic suppression and maintenance in antiretroviral therapy naive adults living with HIV
Active, not recruitingCTIS2023-504993-40-00
Start: 2024-02-14Target: 378Updated: 2025-04-04
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants
Active, not recruitingCTIS2022-502099-22-01
Start: 2024-04-29Target: 82Updated: 2025-08-22
Phase 3 Double-Blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/ Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People with HIV-1
RecruitingCTIS2023-510022-33-00
Start: 2024-10-02Target: 120Updated: 2025-12-05
DTG/3TC vs BIC/FTC/TAF maintenance therapy in people living with HIV: an open-label randomized clinical trial
CompletedCTIS2024-515167-56-00
Start: 2021-06-22End: 2025-03-13Target: 555Updated: 2025-06-04
A Phase 3, Randomized, Double-Blind, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir (B/F/TAF).
Active, not recruitingCTIS2024-514046-37-00
Start: 2025-01-16Target: 87Updated: 2026-01-19
Phase 4
Safety, Tolerability, and Efficacy of a Dose Reduction Strategy Based on Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-infected Adults
CompletedNCT05602506
Start: 2022-11-15End: 2024-06-05Updated: 2025-03-11
A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF after Discontinuing Injectable CAB + RPV
CompletedCTIS2023-506660-13-00
Start: 2024-03-07End: 2025-02-04Target: 10Updated: 2025-02-04
Impact of Doravirine in Liver Steatosis and Fibrosis in PLWH. A pilot, proof of concept study (DORALI Study)
RecruitingCTIS2023-504952-87-00
Start: 2025-01-13Target: 50Updated: 2024-09-18
Phase IV, Randomized, Multicenter, Double-Blind Clinical Trial Designed to Evaluate the Safety and Appropriateness of Switching from DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control, and Neuropsychiatric Vulnerabilities: MIND Study
CompletedCTIS2024-511951-16-00
Start: 2022-08-30End: 2024-08-07Target: 84Updated: 2024-05-13
Virological and immunological assessment in HIV positive participants on 2DR versus 3DR in a prospective randomized controlled switch trial.
Active, not recruitingCTIS2024-515265-34-00
Start: 2020-05-26Target: 134Updated: 2024-10-09
Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA)
CompletedCTIS2024-515487-31-00
End: 2025-12-12Target: 163Updated: 2024-10-22