At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating DOR/ISL, BIC/FTC/TAF, and 2 other interventions for HIV Infection. Completed, enrolled 643 participants across 89 sites in 11 countries.
Detailed 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.
Study Details
Timeline
Interventions
100 mg DOR/ 0.75 ISL FDC single tablet taken orally once daily
50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily
Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily
Placebo to FDC DOR/ISL in a single tablet taken orally, once daily