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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

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitaetsspital Basel ( Site 2602)
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status
Inselspital Universitaetsspital Bern ( Site 2603)
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status
Hopitaux Universitaires de Geneve HUG ( Site 2604)
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status
CHUV (centre hospitalier universitaire vaudois) ( Site 2605)
Coordinator of this site? Confirm its status
LausanneSwitzerlandUnknown status
Universitaetsspital Zuerich ( Site 2601)
Coordinator of this site? Confirm its status
ZuerichSwitzerlandUnknown status
Centre Hospitalier Universitaire D Orleans
Coordinator of this site? Confirm its status
Orleans Cedex 1FranceCompleted
Hopital Saint Louis
Coordinator of this site? Confirm its status
ParisFranceCompleted
Hopital Saint Antoine
Coordinator of this site? Confirm its status
Paris Cedex 12FranceCompleted
Saint Hope Foundation, Inc. ( Site 2716)
Coordinator of this site? Confirm its status
BellaireUnited StatesUnknown status
Infectious Disease Specialists Of Atlanta PC ( Site 2704)
Coordinator of this site? Confirm its status
DecaturUnited StatesUnknown status
Texas Centers for Infectious Disease Associates P.A. ( Site 2709)
Coordinator of this site? Confirm its status
Fort WorthUnited StatesUnknown status
Midway Immunology and Research ( Site 2713)
Coordinator of this site? Confirm its status
Ft. PierceUnited StatesUnknown status
Kansas City CARE Clinic ( Site 2703)
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
DCOL Center for Clinical Research ( Site 2715)
Coordinator of this site? Confirm its status
LongviewUnited StatesUnknown status
Men's Health Foundation ( Site 2710)
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Pueblo Family Physicians ( Site 2702)
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Chatham County Health Department ( Site 2707)
Coordinator of this site? Confirm its status
SavannahUnited StatesUnknown status
Triple O Research Institute, P.A. ( Site 2712)
Coordinator of this site? Confirm its status
West Palm BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.