MTN-025

HOPE Logo

MTN-025, the HIV Open-label Prevention Extension (HOPE) trial, was a multi-site, open-label, Phase 3B trial. Eligible HIV-uninfected former ASPIRE participants were offered a silicone elastomer VR containing 25 mg of dapivirine. Participants could choose not to accept study product at any time and still take part in the study. Study follow-up visits occurred monthly for the first 3 months and quarterly thereafter for 12 months, reflecting a transition to a more real-world type of follow-up (versus a clinical trial approach). The primary objectives of the HOPE study were to assess adherence to and safety of the monthly dapivirine vaginal ring in an open-label setting. Secondary objectives included assessing HIV-1 incidence and HIV-1 antiretroviral resistance. Former ASPIRE participants who chose not to take part in MTN-025 had the option of completing behavioral questionnaires and a subset were selected for qualitative evaluation assessing reasons for non-interest in enrolling (decliner population).

MTN-025 (HOPE) completed follow-up on October 10, 2018. Final results of MTN-025 were presented at the 10th International AIDS Society (IAS) Conference on HIV Science held on July 21-24, 2019 in Mexico City, Mexico. The primary manuscript was published in Lancet HIV on February 1, 2021.

Protocol Chair(s)
Baeten, Jared (Protocol Chair)
Mgodi, Nyaradzo (Protocol Co-Chair)
Palanee-Phillips, Thesla (Protocol Co-Chair)
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
Participants off Study and Primary Analysis Completed
Formulation
Vaginal Ring
Drug
Dapivirine
Study Focus/Product Administration
Vaginal
Study Type
Behavioral
Efficacy
Safety
Study Phase
Phase IIIB
Countries
Malawi
South Africa
Uganda
Zimbabwe
Population
Women (cisgender women, non‐transgender women)
Funder(s)
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
Sponsor(s)
International Partnership for Microbicides

Source URL: https://www.mtnstopshiv.org/research/studies/mtn-025