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BIC/FTC/TAF

DRUG10 trials

Sponsors

Merck Sharp & Dohme LLC, Prism Health North Texas, Carmen Hidalgo Tenorio, José Antonio Mata Marín

Conditions

ARTBMDBody Weight ChangesFastingHIV - Human Immunodeficiency VirusHIV InfectionHIV InfectionsHIV-1 Infection

Phase 2

Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]
CompletedNCT04564547
Merck Sharp & Dohme LLCHIV-1 Infection
Start: 2021-03-09End: 2025-01-30Updated: 2026-01-26
A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)
Active, not recruitingNCT06891066
Merck Sharp & Dohme LLCHuman Immunodeficiency Virus Type 1 (HIV-1) Infection
Start: 2025-04-14End: 2031-09-30Target: 150Updated: 2025-10-16
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
RecruitingNCT07266831
Merck Sharp & Dohme LLCHuman Immunodeficiency Virus Type 1 (HIV-1) Infection
Start: 2025-12-18End: 2030-04-03Target: 570Updated: 2026-03-27

Phase 3

Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
CompletedNCT04223791
Merck Sharp & Dohme LLCHIV Infection
Start: 2020-02-18End: 2025-02-27Updated: 2026-03-27
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 (MK-8591A-020)
CompletedNCT04233879
Merck Sharp & Dohme LLCHIV-1 Infection
Start: 2020-02-28End: 2025-01-29Updated: 2026-01-28
Doravirine and Weight Gain in Antiretroviral Naive
WithdrawnNCT05457530
Prism Health North TexasART, BMD, Body Weight Changes +5
Start: 2022-08-01End: 2023-05-03Updated: 2023-05-12
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) (MK-8591A-052)
Active, not recruitingNCT05630755
Merck Sharp & Dohme LLCHIV-1 Infection
Start: 2023-02-17End: 2028-08-04Updated: 2025-11-18
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
Active, not recruitingNCT05705349
Merck Sharp & Dohme LLCHIV-1 Infection
Start: 2023-03-08End: 2029-08-05Updated: 2025-10-23
DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity
RecruitingNCT07075146
José Antonio Mata MarínHIV - Human Immunodeficiency Virus, Obesity, Overweight and/or Obesity
Start: 2025-05-05End: 2028-08-01Target: 306Updated: 2025-08-24

Phase 4

Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW)
CompletedNCT06177574
Carmen Hidalgo TenorioHIV Infections
Start: 2020-10-27End: 2023-10-30Updated: 2023-12-20

Related Papers

P-377. Efficacy and Safety by Age After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily: Week 48 Results from Two Phase 3 Randomized, Active-Controlled Studies in Adults Living with HIV-1
Open Forum Infectious Diseases2026-01-01
P-389. Switching to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily Maintains Viral Suppression Through Week 48 in the Presence of Archived NNRTI Resistance-Associated Mutations or M184I/V in Proviral DNA
Open Forum Infectious Diseases2026-01-01
P-364. Efficacy and Safety by Sex Assigned at Birth After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily: Week 48 Results from Two Phase 3 Randomized, Active-Controlled Studies in Adults Living with HIV-1
Open Forum Infectious Diseases2026-01-01
Impact of bictegravir/emtricitabine/tenofovir alafenamide on health-related quality of life and economic outcomes in HIV care: Substudy of the BIC-NOW clinical trial
PLoS ONE2025-09-221 citations
Doravirine/Islatravir (100/0.75 mg) Once-Daily Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide as Initial HIV-1 Treatment: 48-Week Results From a Phase 3, Randomized, Controlled, Double-Blind, Noninferiority Trial
Clinical Infectious Diseases2025-03-132 citations
Pharmacokinetics of islatravir in participants with moderate hepatic impairment
Antimicrobial Agents and Chemotherapy2025-03-05
Switch to fixed-dose doravirine (100 mg) with islatravir (0·75 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, randomised, controlled, double-blind, non-inferiority trial.
2024-05-0812 citations
Bictegravir/emtricitabine/tenofovir alafenamide as first-line treatment in naïve HIV patients in a rapid-initiation model of care: BIC-NOW clinical trial.
2024-04-0211 citations