Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
- Conditions
- HIVHIV Pre-exposure Prophylaxis
- Interventions
- Drug: Placebo to MK-8527
- Registration Number
- NCT06045507
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
- 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
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo to MK-8527 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. MK-8527 Medium Dose QM MK-8527 Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period. MK-8527 High Dose QM MK-8527 Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period. MK-8527 Low Dose QM MK-8527 Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
- Primary Outcome Measures
Name Time Method Number of Participants Discontinuing From Study Therapy Due to AE Up to ~20 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants With ≥1 Adverse Event (AE) Up to ~28 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of MK-8527 Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose The Cmax of MK-8527 will be determined.
Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose The AUC0-last of MK-8527 will be determined.
Trial Locations
- Locations (18)
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041)
🇺🇸Pittsburgh, Pennsylvania, United States
Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027)
🇿🇦Johannesburg, Gauteng, South Africa
Helen Joseph Hospital ( Site 0024)
🇿🇦Johannesburg, Gauteng, South Africa
Desmond Tutu Health Foundation ( Site 0021)
🇿🇦Cape Town, Western Cape, South Africa
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057)
🇺🇸Seattle, Washington, United States
Bridge HIV- San Francisco Department of Public Health ( Site 0042)
🇺🇸San Francisco, California, United States
Qhakaza Mbokodo Research Clinic ( Site 0026)
🇿🇦Ladysmith, Kwazulu-Natal, South Africa
Sheba Medical Center ( Site 0001)
🇮🇱Ramat Gan, Israel
Rambam Health Care Campus ( Site 0003)
🇮🇱Haifa, Israel
Josha Research ( Site 0023)
🇿🇦Bloemfontein, Free State, South Africa
Hadassah Medical Center ( Site 0002)
🇮🇱Jerusalem, Israel
Velocity Clinical Research, North Hollywood ( Site 0054)
🇺🇸North Hollywood, California, United States
Community Medical Care Center ( Site 0056)
🇺🇸Immokalee, Florida, United States
Velocity Clinical Research, Hallandale Beach ( Site 0052)
🇺🇸Hallandale Beach, Florida, United States
Fenway Health ( Site 0043)
🇺🇸Boston, Massachusetts, United States
Velocity Clinical Research Rockville ( Site 0048)
🇺🇸Rockville, Maryland, United States
Albuquerque Clinical Trials, Inc. ( Site 0044)
🇺🇸Albuquerque, New Mexico, United States
Prism Health North Texas, Oak Cliff Health Center ( Site 0045)
🇺🇸Dallas, Texas, United States