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Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)

NCT04644029 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2026-02-04

Study results available
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Summary

This study will evaluate whether oral islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenofovir disoproxil (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections.

Conditions

  • HIV-I
  • Human Immunodeficiency Virus Type 1
  • Prophylaxis

Interventions

DRUG

Islatravir

Oral 60 mg tablet administered once monthly during Part 1.

DRUG

Placebo to FTC/TDF

0 mg tablet administered once daily during Part 1.

DRUG

FTC/TDF

Each tablet contains 200 mg emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg tenofovir disoproxil fumarate or 201.22 mg tenofovir disproxil phosphate), administered orally once daily in Parts 1, 2, and 3.

DRUG

Placebo to ISL

0 mg tablet administered orally once monthly in Part 1.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2023-07-18
Completion
2024-06-11
FDA Drug
Yes

Countries

  • United States
  • South Africa
  • Uganda

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 NCT04644029 on ClinicalTrials.gov