Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
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|ClinicalTrials.gov Identifier: NCT02858037|
Recruitment Status : Completed
First Posted : August 8, 2016
Results First Posted : October 25, 2022
Last Update Posted : October 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Combination Product: Dapivirine Vaginal Ring||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1456 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to be replaced each month for a total period of 12 months of use.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women|
|Actual Study Start Date :||July 18, 2016|
|Actual Primary Completion Date :||October 10, 2018|
|Actual Study Completion Date :||October 10, 2018|
Experimental: HIV Open-label Prevention
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women
MTN-020:NCT01617096 MTN-025: NCT02858037
Combination Product: Dapivirine Vaginal Ring
Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
- The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women [ Time Frame: 13 months ]Number of participants Grade 2, Grade 3, and all serious Adverse Events.
- Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women [ Time Frame: 13 months ]By measuring the residual levels of dapivirine in returned used vaginal rings.
- Incidence of HIV-1 Infection [ Time Frame: 13 months ]HIV-1 infection as measured by the protocol algorithm
- Number of Participant Who Acquired HIV-1 With HIV-1 Drug Resistance Associated Mutations. [ Time Frame: 13 months ]HIV-1 drug resistance mutations among participants who acquire HIV-1, as measured by standard genotype analysis and more sensitive methods to detect low frequency drug-resistant variants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858037
|Study Director:||John Steytler||International Partnership for Microbicides|