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Primary Objective

  • Assess the safety of dapivirine (25 mg) administered in a silicone elastomer vaginal matrix ring (VR) in HIV-uninfected postmenopausal women, when inserted once every 4 weeks during 12 weeks of study product use

Study Summary
MTN-024/IPM 031 was a multi-center, two-arm, randomized, double blind, placebo-controlled Phase 2a trial. The study enrolled 96 healthy, HIV-uninfected, post-menopausal females, 45-65 (inclusive) years of age. Participants were randomized in a 3:1 ratio to one of two study groups: placebo VR or dapivirine (25 mg) VR. Each enrolled participant was followed for approximately 13 weeks (12 weeks on study product and a final phone call one week after end of study product use). In addition to the primary objective stated above, the MTN-024/IPM 031 trial evaluated additional secondary objectives including acceptability of and adherence to a dapivirine (25 mg) VR when inserted once every 4 weeks for a 12-week period in HIV uninfected postmenopausal women, as well as local and systemic dapivirine exposure. The dapivirine (25 mg) VR was evaluated in ASPIRE and other studies in women who are 18 to 45 years of age. MTN-024/IPM 031 filled a gap in the dapivirine VR research portfolio, by providing the necessary safety and acceptability data in sexually-active, postmenopausal females.

MTN-024 competed follow-up on April 27, 2015. Primary results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) held on February 22-25, 2016, in Boston, MA. The primary manuscript was published in Clinical Infectious Diseases in March 2019. A total of three papers have been published from this study.

Primary Results
Dapivirine VRs were safe and well-tolerated in postmenopausal women. The mean age of the 96 enrolled participants was 56.8 years (range 46-65); 66% were white, 31% were black, and 3% were of “other” race. Retention was 97%. There was no difference in the incidence of related Grade 2 or higher genital, genitourinary, or reproductive system AEs in the dapivirine vs placebo arms (6/72 (8%) vs 3/24 (13%), p=.69) and no difference in Grade 3 or higher AEs in the dapivirine vs placebo arms (4/72 (6%) vs 0/24 (0%), p=.57). Plasma dapivirine levels in postmenopausal women were similar to those in women of reproductive age when compared to published data on dapivirine VR use in reproductive-age women that found mean plasma dapivirine levels of 217.5 pg/mL.

Protocol Chair(s)
Chen, Beatrice (Protocol Chair)
Protocol Title
Phase 2a Safety Study of a Vaginal Matrix Ring Containing Dapivirine in a Post-Menopausal Female Population
DAIDS Protocol ID
11915
Status
Participants off Study and Primary Analysis Completed
Formulation
Vaginal Ring
Drug
Dapivirine
Placebo
Study Focus/Product Administration
Vaginal
Study Type
Behavioral
Safety
Study Phase
Phase IIA
Countries
United States
Population
Post Menopause  
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