Overview

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)

Status:
Active, not recruiting

Trial end date:
2023-08-31

Target enrollment:

Participant gender:

Summary

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to 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.

Phase:

Phase 3

Details

Lead Sponsor:

Merck Sharp & Dohme Corp.

Treatments:

4'-ethynyl-2-fluoro-2'-deoxyadenosine
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Islatravir
Tenofovir