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

NCT05705349 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 537

Last updated 2025-10-23

No results posted yet for this study

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

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.

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
Yes

Timeline & Regulatory

Start
2023-03-08
Primary Completion
2025-10-13
Completion
2029-08-05
FDA Drug
Yes

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

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 NCT05705349 on ClinicalTrials.gov