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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)

NCT04233879 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 599

Last updated 2026-01-28

Study results available
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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.

Conditions

  • HIV-1 Infection

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2022-11-17
Completion
2025-01-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • Colombia
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • South Africa
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04233879 on ClinicalTrials.gov