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Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

NCT04564547 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2026-01-26

Study results available
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Summary

This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.

Conditions

  • HIV-1 Infection

Interventions

DRUG

Islatravir

ISL capsule taken by mouth.

DRUG

Ulonivirine

Ulonivirine tablet taken by mouth.

DRUG

BIC/FTC/TAF

BIC/FTC/TAF tablet taken by mouth.

DRUG

Placebo to ISL

Placebo capsule matched to ISL taken by mouth.

DRUG

Placebo to Ulonivirine

Placebo tablet matched to ulonivirine taken by mouth.

DRUG

Placebo to BIC/FTC/TAF

Placebo tablet matched to BIC/FTC/TAF taken by mouth.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2025-01-30
Completion
2025-01-30
FDA Drug
Yes

Countries

  • United States
  • France
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
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 NCT04564547 on ClinicalTrials.gov