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)

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

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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