NCT04564547CompletedPhase 2
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]
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
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + ulonivirine based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 161 (actual)
- First submitted
- 21 Sept 2020
- Start date
- 9 Mar 2021
- Primary completion date
- 30 Jan 2025
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- NCT number
- NCT04564547
- EU CT number
- 2024-511041-19-00
- EudraCT number
- 2020-003071-18
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 161
- From 9 Mar 2021 to the primary completion date, 30 Jan 2025
- 18 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
- Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
- Has a documented or known virological resistance to ulonivirine or nucleoside/nucleotide reverse transcriptase inhibitors (NNRTI)
Other illness
- Has HIV-2 infection
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\] positive)
- Has a current (active) diagnosis of acute hepatitis due to any cause
Lab values
- Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
Age
- Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
Other
- Is female and expecting to conceive or donate eggs at any time during the study
Who the study is looking for
- Is HIV-1 positive with plasma human immunodeficiency virus type 1 (HIV-1) RNA \<50 copies/mL at screening
- Has been virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) for ≥6 months
- Has a screening CD4+ T-cell count \>200 cells/mm\^3 (completed by the central laboratory)
- Is male or female, at least 18 years of age, at the time of signing the informed consent
- Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsspital Basel ( Site 2602) Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Universitaetsspital Bern ( Site 2603) Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Hopitaux Universitaires de Geneve HUG ( Site 2604) Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| CHUV (centre hospitalier universitaire vaudois) ( Site 2605) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Universitaetsspital Zuerich ( Site 2601) Coordinator of this site? Confirm its status | Zuerich | Switzerland | Unknown status |
| Centre Hospitalier Universitaire D Orleans Coordinator of this site? Confirm its status | Orleans Cedex 1 | France | Completed |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Completed |
| Hopital Saint Antoine Coordinator of this site? Confirm its status | Paris Cedex 12 | France | Completed |
| Saint Hope Foundation, Inc. ( Site 2716) Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Infectious Disease Specialists Of Atlanta PC ( Site 2704) Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Texas Centers for Infectious Disease Associates P.A. ( Site 2709) Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Midway Immunology and Research ( Site 2713) Coordinator of this site? Confirm its status | Ft. Pierce | United States | Unknown status |
| Kansas City CARE Clinic ( Site 2703) Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| DCOL Center for Clinical Research ( Site 2715) Coordinator of this site? Confirm its status | Longview | United States | Unknown status |
| Men's Health Foundation ( Site 2710) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Pueblo Family Physicians ( Site 2702) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Chatham County Health Department ( Site 2707) Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Triple O Research Institute, P.A. ( Site 2712) Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.