Trials / Completed
CompletedNCT01071174
A Safety Study of Dapivirine Vaginal Ring in Africa
A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring With Dapivirine in Healthy, HIV-Negative Women.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 280 (actual)
- Sponsor
- International Partnership for Microbicides, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Dapivirine | Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total) |
| OTHER | Placebo | Vaginal Ring containing no drug substance |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2011-05-01
- Completion
- 2011-07-01
- First posted
- 2010-02-19
- Last updated
- 2011-08-02
Locations
10 sites across 4 countries: Kenya, Malawi, South Africa, Tanzania
Source: ClinicalTrials.gov record NCT01071174. Inclusion in this directory is not an endorsement.