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MTN-036/IPM 047 is a Phase 1, randomized, three-arm, open label trial. The study will assess the safety and pharmacokinetics (PK) of three silicone elastomer intravaginal rings (VRs) containing either 25 mg or 200 mg of the active ingredient dapivirine (DPV) formulated using either polymer 4320 or 4870. Approximately 36 healthy, HIV-uninfected, non-pregnant women between 18-45 years of age will be followed for approximately 97 days. Participants will insert one VR to be used continuously for 90 days (200 mg VRs) or replaced monthly for 3 months (25 mg VR). Accrual is expected to take 6-9 months. MTN-036/IPM 047 will collect local and systemic pharmacokinetic data as well as safety information on the vaginal rings. MTN-036/IPM 047 will also investigate the acceptability of and adherence to the VRs and explore changes in vaginal microflora and biomarkers over 90 days of product use.

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
Closed to Accrual
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