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

NCT06045507

CompletedPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: HIV, HIV Pre-exposure Prophylaxis

Interventions: MK-8527, Placebo to MK-8527

Countries: United States, Israel, South Africa

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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)
Locations (18)
  • North Hollywood, California, United States
  • San Francisco, California, United States
  • Hallandale, Florida, United States
  • Immokalee, Florida, United States
  • Rockville, Maryland, United States
  • Boston, Massachusetts, United States
  • Albuquerque, New Mexico, United States
  • Pittsburgh, Pennsylvania, United States
  • Dallas, Texas, United States
  • Seattle, Washington, United States
  • Haifa, Israel
  • Jerusalem, Israel
  • Ramat Gan, Israel
  • Bloemfontein, Free State, South Africa
  • Johannesburg, Gauteng, South Africa
  • Johannesburg, Gauteng, South Africa
  • Ladysmith, KwaZulu-Natal, South Africa
  • Cape Town, Western Cape, South Africa