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MTN-036/IPM 047 was a Phase 1, three-arm, multi-site, randomized (1:1:1) trial designed to collect data on the PK and safety profile of DPV when administered via silicone elastomer VR containing the active ingredient at three dosage strengths: 25 mg DPV (IPM Ring-004) [Comparator VR]), 100 mg DPV (IPM Ring-008) and 200 mg DPV (IPM Ring-006). Forty-nine healthy, HIV-uninfected, non-pregnant women between 18-45 years of age were enrolled in the study and followed for approximately 97 days. Participants inserted one VR to be used continuously for 90 days (100 mg and 200 mg VRs) or replaced monthly for 3 months (25 mg VR). MTN-036/IPM 047 collected local and systemic pharmacokinetic data as well as safety information on the vaginal rings. The study also investigated the acceptability of and adherence to the VRs and explore changes in vaginal microflora and biomarkers over 90 days of product use. It is hypothesized that plasma, cervicovaginal fluid and cervical tissue DPV levels will be measurable in all women randomized to DPV VRs, that continuous exposure to DPV due to sustained release from the 100 mg and 200 mg VRs for 13 weeks will be safe, and that dose-proportionality will be demonstrated in tissue and systemic PK.

The study completed follow-up on January 23, 2019. Primary results were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) held virtually on March 6-10 in 2021. The primary manuscript is under review at the Journal of the International AIDS Society (JIAS).

Protocol Chair(s)
Liu, Albert (Protocol Chair)
Protocol Title
A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings
DAIDS Protocol ID
30009
Status
Participants off Study and Primary Analysis Completed
Formulation
Vaginal Ring
Drug
Dapivirine
Study Focus/Product Administration
Vaginal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase I  
Countries
United States
Population
Transgender men
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)
IPM
Other Study Info

Phase 1, three-arm, randomized (1:1:1), open-label trial