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Study identifier: NCT04644029 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Terminated

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

Condition: HIV-I · Human Immunodeficiency Virus Type 1 · Prophylaxis  ·  Sponsor: Merck Sharp & Dohme LLC

PhasePhase 3
Planned participants730
Who can joinFemale, 16 Years to 45 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (24)

University of Alabama at Birmingham-UAB Sexual Health Research Clinic (SHRC) ( Site 0064)Birmingham, Alabama, United States
MedStar Health Research Institute (MedStar Physician Based R-MedStar Washington Hospital Center ( SiWashington D.C., District of Columbia, United States
University of Miami Miller School of Medicine-Infectious Disease ( Site 0076)Miami, Florida, United States
Orlando Immunology Center ( Site 0068)Orlando, Florida, United States
Ponce De Leon Center Grady Health ( Site 0066)Atlanta, Georgia, United States
The University of Mississippi Medical Center ( Site 0065)Jackson, Mississippi, United States
KC CARE Health Center-Clinical Trials ( Site 0059)Kansas City, Missouri, United States
Rutgers New Jersey Medical School-Clinical Research Center ( Site 0071)Newark, New Jersey, United States
Bronx Prevention Center ICAP ( Site 0062)The Bronx, New York, United States
The University of North Carolina at Chapel Hill-Medicine ( Site 0056)Chapel Hill, North Carolina, United States
Prisma Health Richland Hospital-Clinical Research Unit ( Site 0069)Columbia, South Carolina, United States
Prism Health North Texas, Oak Cliff Health Center ( Site 0070)Dallas, Texas, United States

+ 12 more locations — full list on the registry record.

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