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NCT01363037 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring
A Phase 1 study, sponsored by International Partnership for Microbicides.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01363037: Completed Phase 1 study, sponsored by International Partnership for Microbicides.
NCT01363037 is a Phase 1 study that has completed, run by International Partnership for Microbicides. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01363037, a Phase 1 study, has completed, sponsored by International Partnership for Microbicides.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by healthy women in the United States.
Primary Outcome
* Genitourinary events Grade 1 or higher 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) judged to be related to study product * Adverse events Grade 2 or higher as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarif
Interventions
- DRUG Dapivirine Vaginal Ring
- DRUG Maraviroc Vaginal Ring
- OTHER Placebo Vaginal Ring
- DRUG Dapivirine-Maraviroc Vaginal Ring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
What the finished NCT01363037 record still lists
NCT01363037 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 4 interventions - of which Dapivirine Vaginal Ring is the first listed.
NCT01363037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01363037 about?
NCT01363037 is a clinical study titled "Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring". The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by healthy women in the United States.
What is the current status of trial NCT01363037?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2011-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01363037?
The interventions under investigation include: Dapivirine Vaginal Ring (DRUG), Maraviroc Vaginal Ring (DRUG), Placebo Vaginal Ring (OTHER), Dapivirine-Maraviroc Vaginal Ring (DRUG).
Who is sponsoring clinical trial NCT01363037?
This trial is sponsored by International Partnership for Microbicides, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01363037's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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