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)
NCT ID: NCT04652700
Last Updated: 2025-01-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
494 participants
INTERVENTIONAL
2021-03-15
2023-08-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
In Study Part 2, sponsor personnel not directly involved with blinded safety monitoring will be unblinded to participants' randomized study intervention in Part 1 (personnel involved with Part 2 will remain blinded).
In Study Part 3, al participants, investigators, and Sponsor personnel are unblinded as to the participant's original randomized intervention group.
Study Groups
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Islatravir (ISL) Once Monthly (QM) Group
Participants receive 60 mg tablet of ISL QM, orally plus Placebo to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) tablet once daily (QD) or Placebo to Emtricitabine/Tenofovir Alafenamide (FTC/TAF) tablet QD, orally for up to 24 months of treatment duration.
ISL
ISL 60 mg tablet, QM, orally for up to 24 months
Placebo to FTC/TDF
Placebo FTC/TDF 0 mg tablets QD, orally for up to 24 months
Placebo to FTC/TAF
Placebo FTC/TAF 0 mg tablets QD, orally for up to 24 months
FTC/TDF or FTC/TAF QD Group
Participants receive 200/245 mg or 200/300 mg of FTC/TDF combination tablet, QD, orally or 200/25 mg of FTC/TAF combination tablet, QD, orally at investigator's discretion plus Placebo to ISL tablet QM, orally for up to 24 months of treatment duration.
FTC/TDF
Participants receive 200/245 mg of FTC/TDF combination tablet, QD, orally for up to 24 months
FTC/TAF
Participants receive 200/25 mg of FTC/TAF combination tablet, QD, orally for up to 24 months
Placebo to ISL
Placebo ISL 0 mg tablets QM, orally for up to 24 months.
Interventions
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ISL
ISL 60 mg tablet, QM, orally for up to 24 months
FTC/TDF
Participants receive 200/245 mg of FTC/TDF combination tablet, QD, orally for up to 24 months
FTC/TAF
Participants receive 200/25 mg of FTC/TAF combination tablet, QD, orally for up to 24 months
Placebo to ISL
Placebo ISL 0 mg tablets QM, orally for up to 24 months.
Placebo to FTC/TDF
Placebo FTC/TDF 0 mg tablets QD, orally for up to 24 months
Placebo to FTC/TAF
Placebo FTC/TAF 0 mg tablets QD, orally for up to 24 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is sexually active with male or transgender women (TGW) partners defined as having anal sexual intercourse with a man or TGW at least once in the past month
* Is at high risk for sexually acquiring HIV-1 infection based on self-report of at least 1 of the following: a) Condomless receptive anal intercourse in the 6 months prior to screening occurring outside a mutually monogamous HIV seronegative concordant relationship b) More than 5 partners (anal intercourse) in the 6 months prior to screening c) Any unprescribed stimulant drug use in the 6 months prior to screening d) Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening
* Participants 16 or 17 years of age must weigh ≥35 kg. Enrollment for 16- to 17-year-old participants will begin only after completion of the Sentinel Cohort IA and review of IA results by the external data monitoring committee (eDMC)
* Has no plans to relocate or travel away from the site for ≥4 consecutive weeks during study participation
Exclusion Criteria
* Has chronic HBV infection or past HBV infection which could indicate risk for Hepatitis B reactivation
* Has known current or chronic history of liver disease or known hepatic or biliary abnormalities, unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction
* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer or in situ anal cancers
* Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance 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, such that it is not in the best interest of the participant to enroll
* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
* Is currently receiving or is anticipated to require any prohibited therapies outlined in the study from 30 days prior to Day 1 through the duration of the study
* Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device, within 30 days prior to Day 1 through the duration of the study
* Has exclusionary laboratory values within 45 days prior to Day 1
16 Years
MALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0007)
Birmingham, Alabama, United States
UCLA Center for Clinical AIDS Research and Education ( Site 0011)
Los Angeles, California, United States
Global Research Institute ( Site 0031)
Los Angeles, California, United States
Bridge HIV - San Francisco Department of Public Health ( Site 0003)
San Francisco, California, United States
The GW Medical Faculty Associates-Medicine ( Site 0033)
Washington D.C., District of Columbia, United States
Midway Immunology and Research Center ( Site 0014)
Ft. Pierce, Florida, United States
University of Miami Miller School of Medicine-Infectious Disease ( Site 0029)
Miami, Florida, United States
Orlando Immunology Center ( Site 0010)
Orlando, Florida, United States
Ponce De Leon Center Grady Health ( Site 0032)
Atlanta, Georgia, United States
Howard Brown Health Center ( Site 0004)
Chicago, Illinois, United States
The University of Mississippi Medical Center ( Site 0012)
Jackson, Mississippi, United States
Rutgers New Jersey Medical School-Clinical Research Center ( Site 0017)
Newark, New Jersey, United States
The University of North Carolina at Chapel Hill ( Site 0019)
Chapel Hill, North Carolina, United States
Central Texas Clinical Research ( Site 0002)
Austin, Texas, United States
The Crofoot Research Center ( Site 0025)
Houston, Texas, United States
Centro de Referência e Treinamento DST/AIDS ( Site 0351)
São Paulo, , Brazil
Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 0151)
Paris, Île-de-France Region, France
Center Hospital of the National Center for Global Health and Medicine ( Site 0101)
Shinjyuku-ku, Tokyo, Japan
Via Libre ( Site 0404)
Lima, , Peru
Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0203)
Johannesburg, Gauteng, South Africa
Wits Reproductive Health and HIV Institute (WRHI)-Research Center ( Site 0201)
Johannesburg, Gauteng, South Africa
Desmond Tutu HIV Foundation ( Site 0202)
Cape Town, Western Cape, South Africa
Chulalongkorn University-Pediatrics ( Site 0051)
Bangkok, Bangkok, Thailand
HIV Netherlands Australia Thailand Research Collaboration ( Site 0056)
Bangkok, Bangkok, Thailand
Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 0052
Chiang Mai, , Thailand
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-8591-024
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031200419
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-003309-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8591-024
Identifier Type: -
Identifier Source: org_study_id
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