Trials / Completed
CompletedNCT04223791
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)
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 643 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and efficacy of a switch to Doravirine/Islatravir (DOR/ISL) (MK-8591A) (a fixed dose combination of doravirine 100 mg and islatravir 0.75 mg) in participants living with human immunodeficiency virus-1 (HIV-1) virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to DOR/ISL (MK-8591A) will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DOR/ISL | 100 mg DOR/ 0.75 ISL FDC single tablet taken orally once daily |
| DRUG | BIC/FTC/TAF | 50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily |
| DRUG | Placebo to BIC/FTC/TAF | Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily |
| DRUG | Placebo to FDC DOR/ISL | Placebo to FDC DOR/ISL in a single tablet taken orally, once daily |
Timeline
- Start date
- 2020-02-18
- Primary completion
- 2021-08-26
- Completion
- 2025-02-27
- First posted
- 2020-01-10
- Last updated
- 2026-03-27
- Results posted
- 2022-08-22
Locations
89 sites across 11 countries: United States, Australia, Austria, Canada, Finland, France, Germany, Italy, Japan, Puerto Rico, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04223791. Inclusion in this directory is not an endorsement.