ClinicalTrials.Veeva

Menu
The trial is taking place at:
A

Albuquerque Clinical Trials | Albuquerque, NM

Veeva-enabled site

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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Active, not recruiting
Phase 2

Conditions

HIV
HIV Pre-exposure Prophylaxis

Treatments

Drug: MK-8527
Drug: Placebo to MK-8527

Study type

Interventional

Funder types

Industry

Identifiers

NCT06045507
8527-007

Details and patient eligibility

About

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.

Enrollment

350 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

350 participants in 4 patient groups, including a placebo group

MK-8527 Low Dose QM
Experimental group
Description:
Participants receive oral MK-8527 low dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
Treatment:
Drug: MK-8527
MK-8527 Medium Dose QM
Experimental group
Description:
Participants receive oral MK-8527 medium dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
Treatment:
Drug: MK-8527
MK-8527 High Dose QM
Experimental group
Description:
Participants receive oral MK-8527 high dose QM for 6 months, followed by an 8-week blinded safety follow-up period.
Treatment:
Drug: MK-8527
Placebo to MK-8527
Placebo Comparator group
Description:
Participants receive oral placebo matched to MK-8527 QM for 6 months, followed by an 8-week blinded safety follow-up period.
Treatment:
Drug: Placebo to MK-8527

Trial contacts and locations

18

Loading...

Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems