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NCT06045507 · ClinicalTrials.gov registry record · Phase 2
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
A Phase 2 study of HIV and HIV Pre-exposure Prophylaxis, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 352
- Enrollment target
- 18
- Study locations
NCT06045507: Completed Phase 2 study of HIV and HIV Pre-exposure Prophylaxis, sponsored by Merck Sharp & Dohme.
NCT06045507 is a Phase 2 study of HIV and HIV Pre-exposure Prophylaxis that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 352 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (20% lower). The trial reports 18 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06045507, a Phase 2 study of HIV and HIV Pre-exposure Prophylaxis, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 352 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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 |
What the finished NCT06045507 record still lists
NCT06045507 is an interventional study that assigns participants to a tested intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 303 other HIV trials with a reported enrollment target (20% lower).
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.
NCT06045507 lists 18 locations in 13 states (Other, California, Florida).
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.
What interventions are being tested in trial NCT06045507?
The interventions under investigation include: MK-8527 (DRUG), Placebo to MK-8527 (DRUG).
Who is sponsoring clinical trial NCT06045507?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06045507's enrollment target sits among peer trials
352 59th of 303 higher than 244 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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