Microbicide Trials Network

MTN-025

Details

Protocol 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
DAIDS Protocol ID: 
11985
Status: 
Enrolling

Protocol Chair(s)

Jared Baeten (Protocol Chair)
Nyaradzo Mgodi (Protocol Co-Chair)
Thesla Palanee-Phillips (Protocol Co-Chair)

Description

MTN-025, the HIV Open-label Prevention Extension (HOPE) trial, is a multi-site, open-label, randomized, Phase 3B trial that will be implemented if the dapivirine VR is found to be a safe and effective HIV prevention method in the MTN-020 (ASPIRE) trial.  Eligible HIV-uninfected ASPIRE participants will receive a silicone elastomer VR containing 25 mg of dapivirine, to be replaced monthly, for a total period of 12 months of use. Study follow-up visits will occur monthly for the first 3 months, and quarterly thereafter, reflecting a transition to a more real-world type of follow-up (versus a clinical trial approach).  The study will compare the safety of and participant adherence to dapivirine (25 mg) in a silicone elastomer VR. Should a woman choose not to take part in MTN-025, she will have the option of completing a brief survey and may be selected for qualitative evaluation assessing reasons for non-interest in enrolling.  The HOPE sample size will be contingent upon how many former ASPIRE participants are interested in enrolling, are HIV-negative and otherwise eligible to enroll.

Other Study Info

Funding Agencies:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US Eunice Kennedy Shriver National Institute of  Child Health and Human Development

US National Institute of Mental Health

US National Institutes of Health

IND Sponsor:

International Partnership for Microbicides