NCT05705349

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 537 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	DOR/ISL	Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.
DRUG	BIC/FTC/TAF	Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.
DRUG	Placebo to DOR/ISL	Placebo tablet matched to DOR/ISL tablet taken by mouth.
DRUG	Placebo to BIC/FTC/TAF	Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.

Timeline

• Start date: 2023-03-08
• Primary completion: 2025-10-13
• Completion: 2029-08-05
• First posted: 2023-01-30
• Last updated: 2025-10-23

Locations

131 sites across 21 countries: United States, Argentina, Canada, Chile, Colombia, Dominican Republic, France, Germany, Guatemala, Israel, Japan, Kenya, Malaysia, Mexico, Puerto Rico, South Africa, Spain, Switzerland, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study