Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
Public ClinicalTrials.gov record NCT04644029. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04644029
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 730 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 24, 2021 (Actual)
- Primary completion
- Jul 18, 2023 (Actual)
- Completion
- Jun 11, 2024 (Actual)
- Last update posted
- Feb 4, 2026
2021 – 2024
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham-UAB Sexual Health Research Clinic (SHRC) ( Site 0064) | Birmingham | Alabama | 35205 | — |
| MedStar Health Research Institute (MedStar Physician Based R-MedStar Washington Hospital Center ( Si | Washington D.C. | District of Columbia | 20010 | — |
| University of Miami Miller School of Medicine-Infectious Disease ( Site 0076) | Miami | Florida | 33136 | — |
| Orlando Immunology Center ( Site 0068) | Orlando | Florida | 32803 | — |
| Ponce De Leon Center Grady Health ( Site 0066) | Atlanta | Georgia | 30308 | — |
| The University of Mississippi Medical Center ( Site 0065) | Jackson | Mississippi | 39216 | — |
| KC CARE Health Center-Clinical Trials ( Site 0059) | Kansas City | Missouri | 64111 | — |
| Rutgers New Jersey Medical School-Clinical Research Center ( Site 0071) | Newark | New Jersey | 07103 | — |
| Bronx Prevention Center ICAP ( Site 0062) | The Bronx | New York | 10451 | — |
| The University of North Carolina at Chapel Hill-Medicine ( Site 0056) | Chapel Hill | North Carolina | 27599 | — |
| Prisma Health Richland Hospital-Clinical Research Unit ( Site 0069) | Columbia | South Carolina | 29203 | — |
| Prism Health North Texas, Oak Cliff Health Center ( Site 0070) | Dallas | Texas | 75208 | — |
| West Virginia University-Department of Medicine ( Site 0061) | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04644029, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2026 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04644029 live on ClinicalTrials.gov.