MTN-034

REACH Logo

MTN-034, 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 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.

Protocol Chair(s)
Celum, Connie (Protocol Co-Chair)
Nair, Gonasagrie (Lulu) (Protocol Chair)
Ngure, Kenneth (Protocol Co-Chair)
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 and Young Adult Female Population
DAIDS Protocol ID
12066
Status
Pending
Formulation
Oral Tablet
Vaginal Ring
Drug
Dapivirine
Truvada® (emtricitabine +tenofovir disoproxil fumarate)
Study Focus/Product Administration
Oral
Vaginal
Study Type
Behavioral
Pharmacokinetics
Safety
Study Phase
Phase IIA
Countries
Kenya
South Africa
Zimbabwe
Population
Adolescents
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
Gilead Sciences, Inc.
Other Study Info

Phase 2a, randomized, open label, crossover trial


Source URL: https://mtnstopshiv.org/research/studies/mtn-034