Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
NCT ID: NCT06045507
Last Updated: 2026-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
352 participants
INTERVENTIONAL
2023-11-08
2025-02-12
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
Study Groups
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MK-8527 Low Dose QM
Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
MK-8527
MK-8527 capsule
MK-8527 Medium Dose QM
Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
MK-8527
MK-8527 capsule
MK-8527 High Dose QM
Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
MK-8527
MK-8527 capsule
Placebo to MK-8527
Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
Placebo to MK-8527
Placebo capsule matched to MK-8527
Interventions
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MK-8527
MK-8527 capsule
Placebo to MK-8527
Placebo capsule matched to MK-8527
Eligibility Criteria
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Inclusion Criteria
* Has low-risk of HIV infection
* Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse
Exclusion Criteria
* Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid \[RNA\])
* Prior use of MK-8527 or islatravir (MK-8591)
18 Years
65 Years
ALL
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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Velocity Clinical Research, North Hollywood ( Site 0054)
North Hollywood, California, United States
Bridge HIV- San Francisco Department of Public Health ( Site 0042)
San Francisco, California, United States
Velocity Clinical Research, Hallandale Beach ( Site 0052)
Hallandale, Florida, United States
Community Medical Care Center ( Site 0056)
Immokalee, Florida, United States
Velocity Clinical Research Rockville ( Site 0048)
Rockville, Maryland, United States
Fenway Health ( Site 0043)
Boston, Massachusetts, United States
Albuquerque Clinical Trials, Inc. ( Site 0044)
Albuquerque, New Mexico, United States
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041)
Pittsburgh, Pennsylvania, United States
Prism Health North Texas, Oak Cliff Health Center ( Site 0045)
Dallas, Texas, United States
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057)
Seattle, Washington, United States
Rambam Health Care Campus ( Site 0003)
Haifa, , Israel
Hadassah Medical Center ( Site 0002)
Jerusalem, , Israel
Sheba Medical Center ( Site 0001)
Ramat Gan, , Israel
Josha Research ( Site 0023)
Bloemfontein, Free State, South Africa
Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027)
Johannesburg, Gauteng, South Africa
Helen Joseph Hospital ( Site 0024)
Johannesburg, Gauteng, South Africa
Qhakaza Mbokodo Research Clinic ( Site 0026)
Ladysmith, KwaZulu-Natal, South Africa
Desmond Tutu Health Foundation ( Site 0021)
Cape Town, Western Cape, South Africa
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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8527-007
Identifier Type: -
Identifier Source: org_study_id
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