Microbicide Trials Network

MTN-036/IPM 047

Details

Protocol Title: 
A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings
DAIDS Protocol ID: 
30009
Status: 
Enrolling

Protocol Chair(s)

Albert Liu (Protocol Chair)

Description

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.

Other Study Info

Sponsor:

·       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

 

Co-Sponsor:

·       IPM

Study Design:

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