Microbicide Trials Network

MTN-034/IPM 045

Details

Protocol Title: 
A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent Female Population
DAIDS Protocol ID: 
12066
Status: 
Pending

Protocol Chair(s)

Connie Celum (Protocol Co-Chair)
Gonasagrie (Lulu) Nair (Protocol Chair)
Kenneth Ngure (Protocol Co-Chair)

Description


MTN-034/IPM 045, a Phase 2a, multi-site, randomized, open-label, crossover study, will enroll approximately 300 healthy, HIV-uninfected adolescent females between the ages of 16 - 21 years old (inclusive). Participants will be randomized to product sequence and will use a silicone elastomer vaginal matrix ring (VR) containing 25 mg of dapivirine (DPV) to be replaced each month for a total period of 6 months of use, as well as take oral emtricitabine/tenofovir (FTC/TDF) tablets daily for a 6 month product use period, and then complete a final 6-month period in which the participant can choose to use the ring, Truvada, or neither.   The primary purpose of this trial is to collect safety and adherence data over the course of study product use.   MTN-034/IPM 045 will also examine the acceptability of the study products.  It is anticipated that this study will take approximately 12 months at each site to enroll the target sample size. Each participant will be followed for approximately 73 weeks.

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

 

Pharmaceutical Company Collaborator: Gilead Sciences, Inc.

 

Study Design: Phase 2a, randomized, open label, crossover trial