Clinical trial NCT06045507: Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
HIV Pre-exposure Prophylaxis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With ≥1 Adverse Event (AE)
timeFrame: Up to ~28 weeks
measure: Number of Participants Discontinuing From Study Therapy Due to AE
timeFrame: Up to ~20 weeks
Secondary outcomes:
measure: Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527
timeFrame: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose
measure: Maximum Plasma Concentration (Cmax) of MK-8527
timeFrame: Day 1: predose and 0.5, 4, and 24 hours postdose. Week 20: 0.5, 4, and 24 hours postdose
Other outcomes:
Locations:
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood ( Site 0054)
state: California
city: San Francisco
country: United States
facility: Bridge HIV- San Francisco Department of Public Health ( Site 0042)
state: California
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 0052)
state: Florida
city: Immokalee
country: United States
facility: Community Medical Care Center ( Site 0056)
state: Florida
city: Rockville
country: United States
facility: Velocity Clinical Research Rockville ( Site 0048)
state: Maryland
city: Boston
country: United States
facility: Fenway Health ( Site 0043)
state: Massachusetts
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc. ( Site 0044)
state: New Mexico
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041)
state: Pennsylvania
city: Dallas
country: United States
facility: Prism Health North Texas, Oak Cliff Health Center ( Site 0045)
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057)
state: Washington
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0003)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 0002)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center ( Site 0001)
city: Bloemfontein
country: South Africa
facility: Josha Research ( Site 0023)
state: Free State
city: Johannesburg
country: South Africa
facility: Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Helen Joseph Hospital ( Site 0024)
state: Gauteng
city: Ladysmith
country: South Africa
facility: Qhakaza Mbokodo Research Clinic ( Site 0026)
state: Kwazulu-Natal
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation ( Site 0021)
state: Western Cape
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: