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NCT02356302 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of Intravaginal Rings Containing Vicriviroc (MK-4176) and/or MK-2048
A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 2
- Study locations
NCT02356302: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02356302 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02356302, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 2
- Study locations
Study Summary
Research is currently underway to develop new HIV prevention strategies. Intravaginal rings (IVRs) are one drug delivery method that is currently being studied. This study will evaluate the safety and pharmacokinetics of IVRs containing vicriviroc, MK-2048, and a combination of vicriviroc/MK-2048, in healthy, HIV-uninfected women.
Primary Outcome
As defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009), Addendum 1, (Female Genital Grading Table for Use in Microbicide Studies)
Conditions Studied
Interventions
- DEVICE Vicriviroc (MK-4176) Intravaginal Ring (IVR)
- DEVICE MK-2048 IVR
- DEVICE MK-2048A IVR
- DEVICE Placebo IVR
Study Locations (2)
Alabama
- Alabama CRS - Birmingham
Pennsylvania
- University of Pittsburgh CRS - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
What the finished NCT02356302 record still lists
NCT02356302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (89% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Vicriviroc (MK-4176) Intravaginal Ring (IVR) is the first listed.
NCT02356302 reports a single indexed study location in Alabama, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02356302 about?
NCT02356302 is a clinical study titled "Safety and Pharmacokinetics of Intravaginal Rings Containing Vicriviroc (MK-4176) and/or MK-2048". Research is currently underway to develop new HIV prevention strategies. Intravaginal rings (IVRs) are one drug delivery method that is currently being studied. This study will evaluate the safety and pharmacokinetics of IVRs containing vicriviroc, MK-2048, and a combination of vicriviroc/MK-2048, i...
What is the current status of trial NCT02356302?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2015-05. Estimated completion is 2016-03.
What conditions does trial NCT02356302 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT02356302?
The interventions under investigation include: Vicriviroc (MK-4176) Intravaginal Ring (IVR) (DEVICE), MK-2048 IVR (DEVICE), MK-2048A IVR (DEVICE), Placebo IVR (DEVICE).
Who is sponsoring clinical trial NCT02356302?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02356302 being conducted?
This trial has 2 study locations across Alabama, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02356302's enrollment target sits among peer trials
48 367th of 542 higher than 168 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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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