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Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06045507
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : February 15, 2024
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV HIV Pre-exposure Prophylaxis Drug: MK-8527 Drug: Placebo to MK-8527 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection
Actual Study Start Date : November 8, 2023
Estimated Primary Completion Date : February 18, 2025
Estimated Study Completion Date : February 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arm Intervention/treatment
Experimental: 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.
Drug: MK-8527
MK-8527 capsule

Experimental: 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.
Drug: MK-8527
MK-8527 capsule

Experimental: 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.
Drug: MK-8527
MK-8527 capsule

Placebo Comparator: 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.
Drug: Placebo to MK-8527
Placebo capsule matched to MK-8527




Primary Outcome Measures :
  1. Number of Participants With ≥1 Adverse Event (AE) [ Time Frame: 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.

  2. Number of Participants Discontinuing From Study Therapy Due to AE [ Time Frame: 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.


Secondary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 [ Time Frame: 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.

  2. Maximum Plasma Concentration (Cmax) of MK-8527 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
  • Has low-risk of HIV infection
  • Males: if capable of producing sperm, the participant agrees to the following during the intervention period and for ≥8 weeks after the last dose of study intervention: abstains from penile-vaginal intercourse OR uses approved contraception unless confirmed to be azoospermic.
  • Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception or is abstinent from penile-vaginal intercourse

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045507


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, California
Velocity Clinical Research, North Hollywood ( Site 0054) Recruiting
North Hollywood, California, United States, 91606
Contact: Study Coordinator    619-859-1267      
Bridge HIV- San Francisco Department of Public Health ( Site 0042) Recruiting
San Francisco, California, United States, 94102
Contact: Study Coordinator    415-793-8877      
United States, Florida
Velocity Clinical Research, Hallandale Beach ( Site 0052) Recruiting
Hallandale Beach, Florida, United States, 33009
Contact: Study Coordinator    954-243-0088      
Community Medical Care Center ( Site 0056) Recruiting
Immokalee, Florida, United States, 34142
Contact: Study Coordinator    239-657-5800      
United States, Maryland
Velocity Clinical Research, Rockville ( Site 0048) Recruiting
Rockville, Maryland, United States, 20854
Contact: Study Coordinator    301-762-5020      
United States, Massachusetts
Fenway Health ( Site 0043) Recruiting
Boston, Massachusetts, United States, 02215
Contact: Study Coordinator    617-927-6087      
United States, New Mexico
Albuquerque Clinical Trials, Inc. ( Site 0044) Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Study Coordinator    505-224-7407      
United States, Texas
Prism Health North Texas, Oak Cliff Health Center ( Site 0045) Recruiting
Dallas, Texas, United States, 75208
Contact: Study Coordinator    214-673-9463      
United States, Washington
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057) Recruiting
Seattle, Washington, United States, 98104
Contact: Study Coordinator    206-520-4268      
Israel
Rambam Health Care Campus ( Site 0003) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    97247776750      
Hadassah Medical Center ( Site 0002) Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    97226779372      
Sheba Medical Center ( Site 0001) Recruiting
Ramat Gan, Israel, 5265601
Contact: Study Coordinator    97235309657      
South Africa
Josha Research ( Site 0023) Recruiting
Bloemfontein, Free State, South Africa, 9301
Contact: Study Coordinator    +27825724468      
Helen Joseph Hospital ( Site 0024) Recruiting
Johannesburg, Gauteng, South Africa, 2092
Contact: Study Coordinator    +27834158967      
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
Additional Information:
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT06045507    
Other Study ID Numbers: 8527-007
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: February 15, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections