NCT04233879

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)

A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 599 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL \[also known as MK-8591A\]) in treatment-naïve participants living with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

Detailed description

Double-blind treatment with the assigned intervention occurs from Day 1 to Week 96, followed by an open-label portion up to Week 144. Participants who benefit from treatment in the opinion of the Investigator may continue their assigned intervention up to Week 168 (or until they have the option to enroll in a DOR/ISL 100 mg/0.25 mg study, whichever is sooner).

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	DOR/ISL	100 mg DOR/0.75 mg ISL FDC single tablet taken once daily by mouth.
DRUG	BIC/FTC/TAF	BIC/FTC/TAF 50/200/25 mg FDC single tablet taken once daily by mouth.
DRUG	Placebo to BIC/FTC/TAF	Placebo single tablet matched to BIC/FTC/TAF taken by mouth.
DRUG	Placebo to DOR/ISL	Placebo single tablet matched to DOR/ISL taken by mouth.

Timeline

• Start date: 2020-02-28
• Primary completion: 2022-11-17
• Completion: 2025-01-29
• First posted: 2020-01-18
• Last updated: 2026-01-28
• Results posted: 2023-11-21

Locations

95 sites across 13 countries: United States, Argentina, Canada, Chile, Colombia, France, Germany, Israel, Italy, Japan, South Africa, Spain, Taiwan

Regulatory

• FDA-regulated drug study