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]
Public ClinicalTrials.gov record NCT04564547. 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 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily
Study identification
- NCT ID
- NCT04564547
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Merck Sharp & Dohme LLC
- Industry
- Enrollment
- 161 participants
Conditions and interventions
Conditions
Interventions
- BIC/FTC/TAF Drug
- Islatravir Drug
- Placebo to BIC/FTC/TAF Drug
- Placebo to ISL Drug
- Placebo to Ulonivirine Drug
- Ulonivirine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 8, 2021
- Primary completion
- Jan 29, 2025
- Completion
- Jan 29, 2025
- Last update posted
- Jan 25, 2026
2021 – 2025
United States locations
- U.S. sites
- 10
- U.S. states
- 6
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pueblo Family Physicians ( Site 2702) | Phoenix | Arizona | 85015 | — |
| Men's Health Foundation ( Site 2710) | Los Angeles | California | 90069 | — |
| Midway Immunology and Research ( Site 2713) | Ft. Pierce | Florida | 34982 | — |
| Triple O Research Institute, P.A. ( Site 2712) | West Palm Beach | Florida | 33407 | — |
| Infectious Disease Specialists Of Atlanta PC ( Site 2704) | Decatur | Georgia | 30033 | — |
| Chatham County Health Department ( Site 2707) | Savannah | Georgia | 31410 | — |
| Kansas City CARE Clinic ( Site 2703) | Kansas City | Missouri | 64111 | — |
| Saint Hope Foundation, Inc. ( Site 2716) | Bellaire | Texas | 77401 | — |
| Texas Centers for Infectious Disease Associates P.A. ( Site 2709) | Fort Worth | Texas | 76104 | — |
| DCOL Center for Clinical Research ( Site 2715) | Longview | Texas | 75605 | — |
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 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04564547, 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 Jan 25, 2026 · Synced May 14, 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 protocol, eligibility criteria, and contact information for NCT04564547 live on ClinicalTrials.gov.