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A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)

NCT07266831 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2026-05-19

No results posted yet for this study

Summary

Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.

Conditions

  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Interventions

DRUG

ISL

ISL 2 x 1 mg oral capsules administered qw for 96 weeks

DRUG

ULO

ULO 2 x 100 mg oral tablets administered qw for 96 weeks

DRUG

BIC/FTC/TAF

BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks

DRUG

Placebo for BIC/FTC/TAF

BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks

DRUG

Placebo to ISL/ULO

ISL/ULO-matching placebo oral tablets administered qw for 96 weeks

DRUG

ISL/ULO

ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks

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
2025-12-18
Primary Completion
2029-03-21
Completion
2030-04-03
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • France
  • Guatemala
  • Mexico
  • South Africa
  • Spain

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 NCT07266831 on ClinicalTrials.gov