Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024)
Public ClinicalTrials.gov record NCT04652700. 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 Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with 48 or 96 weeks of treatment and a minimum follow-up of 42 days.
Study identification
- NCT ID
- NCT04652700
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 494 participants
Conditions and interventions
Conditions
Interventions
- ISL Drug
- FTC/TDF Drug
- FTC/TAF Drug
- Placebo to ISL Drug
- Placebo to FTC/TDF Drug
- Placebo to FTC/TAF Drug
Drug
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- Male
- 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
- Mar 15, 2021 (Actual)
- Primary completion
- Aug 4, 2023 (Actual)
- Completion
- Aug 4, 2023 (Actual)
- Last update posted
- May 5, 2026
2021 – 2023
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0007) | Birmingham | Alabama | 35222 | — |
| UCLA Center for Clinical AIDS Research and Education ( Site 0011) | Los Angeles | California | 90035 | — |
| Global Research Institute ( Site 0031) | Los Angeles | California | 90036 | — |
| Bridge HIV - San Francisco Department of Public Health ( Site 0003) | San Francisco | California | 94102 | — |
| The GW Medical Faculty Associates-Medicine ( Site 0033) | Washington D.C. | District of Columbia | 20037 | — |
| Midway Immunology and Research Center ( Site 0014) | Ft. Pierce | Florida | 34982 | — |
| University of Miami Miller School of Medicine-Infectious Disease ( Site 0029) | Miami | Florida | 33136 | — |
| Orlando Immunology Center ( Site 0010) | Orlando | Florida | 32803 | — |
| Ponce De Leon Center Grady Health ( Site 0032) | Atlanta | Georgia | 30308 | — |
| Howard Brown Health Center ( Site 0004) | Chicago | Illinois | 60613 | — |
| The University of Mississippi Medical Center ( Site 0012) | Jackson | Mississippi | 39216 | — |
| Rutgers New Jersey Medical School-Clinical Research Center ( Site 0017) | Newark | New Jersey | 07103 | — |
| The University of North Carolina at Chapel Hill ( Site 0019) | Chapel Hill | North Carolina | 27599 | — |
| Central Texas Clinical Research ( Site 0002) | Austin | Texas | 78705 | — |
| The Crofoot Research Center ( Site 0025) | Houston | Texas | 77098 | — |
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 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04652700, 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 May 5, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04652700 live on ClinicalTrials.gov.