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NCT06045507 Clinical Trial

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

HIV Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06045507
Other study ID # 8527-007
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 8, 2023
Est. completion date December 5, 2024

Study information
Verified date May 2024
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 350
Est. completion date December 5, 2024
Est. primary completion date December 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK-8527
MK-8527 capsule
• Placebo to MK-8527
Placebo capsule matched to MK-8527

Locations
Country Name City State
Israel Rambam Health Care Campus ( Site 0003) Haifa
Israel Hadassah Medical Center ( Site 0002) Jerusalem
Israel Sheba Medical Center ( Site 0001) Ramat Gan
South Africa Josha Research ( Site 0023) Bloemfontein Free State
South Africa Desmond Tutu Health Foundation ( Site 0021) Cape Town Western Cape
South Africa Helen Joseph Hospital ( Site 0024) Johannesburg Gauteng
South Africa Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027) Johannesburg Gauteng
South Africa Qhakaza Mbokodo Research Clinic ( Site 0026) Ladysmith Kwazulu-Natal
United States Albuquerque Clinical Trials, Inc. ( Site 0044) Albuquerque New Mexico
United States Fenway Health ( Site 0043) Boston Massachusetts
United States Prism Health North Texas, Oak Cliff Health Center ( Site 0045) Dallas Texas
United States Velocity Clinical Research, Hallandale Beach ( Site 0052) Hallandale Beach Florida
United States Community Medical Care Center ( Site 0056) Immokalee Florida
United States Velocity Clinical Research, North Hollywood ( Site 0054) North Hollywood California
United States University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041) Pittsburgh Pennsylvania
United States Velocity Clinical Research Rockville ( Site 0048) Rockville Maryland
United States Bridge HIV- San Francisco Department of Public Health ( Site 0042) San Francisco California
United States Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057) Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Israel,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With =1 Adverse Event (AE) 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. Up to ~28 weeks
Primary Number of Participants Discontinuing From Study Therapy Due to AE 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. Up to ~20 weeks
Secondary Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 The AUC0-last of MK-8527 will be determined. Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose
Secondary Maximum Plasma Concentration (Cmax) of MK-8527 The Cmax of MK-8527 will be determined. Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose
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