NCT06045507

Brief Summary

This double-blind, placebo-controlled study was 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for phase_2 hiv

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2 hiv

Geographic Reach
3 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2025

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 7, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

September 13, 2023

Results QC Date

December 2, 2025

Last Update Submit

January 6, 2026

Conditions

HIVHIV Pre-exposure Prophylaxis

Outcome Measures

Primary Outcomes (2)

  • 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

  • Number of Participants Discontinuing Study Therapy Due to 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 ~20 weeks

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (4)

MK-8527 Low Dose QM

EXPERIMENTAL

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 Medium Dose QM

EXPERIMENTAL

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 High Dose QM

EXPERIMENTAL

Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.

Drug: MK-8527

Placebo to MK-8527

PLACEBO COMPARATOR

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

Interventions

MK-8527DRUG

MK-8527 capsule

MK-8527 High Dose QMMK-8527 Low Dose QMMK-8527 Medium Dose QM
Placebo to MK-8527DRUG

Placebo capsule matched to MK-8527

Placebo to MK-8527

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Velocity Clinical Research, North Hollywood ( Site 0054)

North Hollywood, California, 91606, United States

Location

Bridge HIV- San Francisco Department of Public Health ( Site 0042)

San Francisco, California, 94102, United States

Location

Velocity Clinical Research, Hallandale Beach ( Site 0052)

Hallandale, Florida, 33009, United States

Location

Community Medical Care Center ( Site 0056)

Immokalee, Florida, 34142, United States

Location

Velocity Clinical Research Rockville ( Site 0048)

Rockville, Maryland, 20854, United States

Location

Fenway Health ( Site 0043)

Boston, Massachusetts, 02215, United States

Location

Albuquerque Clinical Trials, Inc. ( Site 0044)

Albuquerque, New Mexico, 87102, United States

Location

University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041)

Pittsburgh, Pennsylvania, 15213, United States

Location

Prism Health North Texas, Oak Cliff Health Center ( Site 0045)

Dallas, Texas, 75208, United States

Location

Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0057)

Seattle, Washington, 98104, United States

Location

Rambam Health Care Campus ( Site 0003)

Haifa, 3109601, Israel

Location

Hadassah Medical Center ( Site 0002)

Jerusalem, 9112001, Israel

Location

Sheba Medical Center ( Site 0001)

Ramat Gan, 5265601, Israel

Location

Josha Research ( Site 0023)

Bloemfontein, Free State, 9301, South Africa

Location

Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027)

Johannesburg, Gauteng, 2000, South Africa

Location

Helen Joseph Hospital ( Site 0024)

Johannesburg, Gauteng, 2092, South Africa

Location

Qhakaza Mbokodo Research Clinic ( Site 0026)

Ladysmith, KwaZulu-Natal, 3370, South Africa

Location

Desmond Tutu Health Foundation ( Site 0021)

Cape Town, Western Cape, 7925, South Africa

Location

Related Links

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme LLC
ClinicalTrialsDisclosure@msd.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

November 8, 2023

Primary Completion

December 12, 2024

Study Completion

February 12, 2025

Last Updated

January 7, 2026

Results First Posted

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

More information

Locations

US(10)IL(3)ZA(5)