To Assess Continued Safety of and Adherence to the Dapivirine (25 mg) Vaginal Ring-004 in Healthy, HIV-negative Women
NCT02862171 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 941
Last updated 2022-10-25
Summary
A follow-on, open label trial to assess continued safety of and adherence to the Dapivirine(25mg) vaginal ring-004 in healthy, HIV-negative women
Conditions
- HIV Prevention
Interventions
- DRUG
-
Dapivirine Vaginal Ring-004
To assess the safety profile of the 25 mg Dapivirine Vaginal Ring-004, when inserted at monthly intervals, in an open-label trial
Sponsors & Collaborators
-
International Partnership for Microbicides, Inc.
lead INDUSTRY
Principal Investigators
-
John Steytler · International Partnership for Microbicides
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-07-12
- Primary Completion
- 2019-01-11
- Completion
- 2019-01-11
- FDA Drug
- Yes
Countries
- South Africa
- Uganda
Study Locations
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