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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)
NCT06045507 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG MK-8527
- DRUG Placebo to MK-8527
Study Locations (18)
Other
- Rambam Health Care Campus ( Site 0003) — Haifa
- Hadassah Medical Center ( Site 0002) — Jerusalem
- Sheba Medical Center ( Site 0001) — Ramat Gan
California
- Velocity Clinical Research, North Hollywood ( Site 0054) — North Hollywood
- Bridge HIV- San Francisco Department of Public Health ( Site 0042) — San Francisco
Florida
- Velocity Clinical Research, Hallandale Beach ( Site 0052) — Hallandale
- Community Medical Care Center ( Site 0056) — Immokalee
Gauteng
- Wits RHI-Wits RHI Ward 21 Clinical Research site ( Site 0027) — Johannesburg
- Helen Joseph Hospital ( Site 0024) — Johannesburg
Maryland
- Velocity Clinical Research Rockville ( Site 0048) — Rockville
Massachusetts
- Fenway Health ( Site 0043) — Boston
New Mexico
- Albuquerque Clinical Trials, Inc. ( Site 0044) — Albuquerque
Pennsylvania
- University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0041) — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2023-11-08 |
| Est. Completion | 2025-02-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06045507
The ClinicalTrials.gov registry entry for NCT06045507 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions — of which MK-8527 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06045507 reports 18 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06045507 about?
NCT06045507 is a clinical study titled "Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)". 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.
What is the current status of trial NCT06045507?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 352 participants. The study started on 2023-11-08. Estimated completion is 2025-02-12.
What conditions does trial NCT06045507 study?
This clinical trial studies the following conditions: HIV, HIV Pre-exposure Prophylaxis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06045507?
The interventions under investigation include: MK-8527 (DRUG), Placebo to MK-8527 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06045507?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06045507 being conducted?
This trial has 18 study locations across California, Florida, Maryland, Massachusetts, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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