Phase 2
Completed N=352
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
HIV · HIV Pre-exposure Prophylaxis
Source: ClinicalTrials.gov NCT06045507 ↗
Enrolled (actual)
352
Serious AEs
1.1%
Results posted
Jan 2026
Primary outcomePrimary: Number of Participants With ≥1 Adverse Event (AE) — 62; 69; 66; 31 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With ≥1 Adverse Event (AE) |
62; 69; 66; 31 | — |
| PRIMARY Number of Participants Discontinuing Study Therapy Due to Adverse Event (AE) |
0; 2; 1; 2 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Dosing to Last Measurable Concentration (AUC0-last) of MK-8527 |
0.132; 0.397; 0.861; 0.129; 0.404; 0.836 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of MK-8527 |
0.0289; 0.0490; 0.113; 0.0320; 0.0538; 0.108 | — |
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)
Data sourced from ClinicalTrials.gov (NCT06045507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.