The Microbicide Trials Network Group 3 Lindsay O. Bryant Danielle M. Campbell Alan D. Johnson Leroy Smith Jr. Kendra M. Taylor May 31, 2016

Background  The Microbicide Trials Network (MTN) was first established in 2006 to identify a safe and effective microbicide for HIV prevention.  From the outset, the MTN has targeted key populations that are at risk for acquiring HIV, including women in sub-Saharan Africa, adolescents, pregnant women and lactating women, and MSM.

Background  The mission of the MTN is to reduce the rate of the sexual transmission of HIV through the development and evaluation of topical (microbicide) products for use in at- risk populations.  To accomplish this mission, the MTN conducts scientifically rigorous, ethically sound and highly efficient clinical studies on the safety, effectiveness, pharmacokinetics and behavioral aspects associated with microbicide use.

Background  Microbicides are products applied inside the vagina or rectum that are intended to protect against HIV though sex.  Vaginal microbicides are being designed in many forms, including gels, films and rings, which release an active ingredient gradually over time.

Background  Anal sex is common among men who have sex with men and practiced by women around the world. According to some estimates, the risk of infection through anal sex is 20 times greater than vaginal sex because the rectal lining, the mucosa, is thinner and much more fragile than the lining of the vagina.

Enrolling Protocol Number Protocol IDProtocol Title MTN Expanded Safety of Tenofovir 1% Gel in Pregnancy and Lactation MTN Phase 1 Evaluation of Coitus on the Pharmacokinetics and Pharmacodynamics of Tenofovir 1% Gel Following Pericoital or Daily Gel Dosing MTN An Observational Cohort Study of Women following HIV-1 Sero- conversion in Microbicide Trials MTN HIV Prevention Agent Pregnancy Exposure Registry MTN A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women

Pending Protocol Number Protocol IDProtocol Title HVTN 095/MTN Phase 1 Safety and Immunogenicity of DNA/NYVAC Prime Boost Vaccination With/Without Emtricitabine/Tenofovir MTN-003D11893 An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial MTN A Phase 1 Crossover Trial Evaluating the Pharmacokinetics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments In Women MTN A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel. MTN Post-Trial Follow-up Safety Study to MTN-003

Pending (Continued) Protocol Number Protocol IDProtocol Title MTN-018B11846 Committed to Having Options for Interventions to Control the Epidemic: A Follow-up Study to MTN Breastfeeding Sub-study MTN-018C11847 Committed to Having Options for Interventions to Control the Epidemic: A Follow-up Study to MTN Pregnancy Sub-study MTN-024/IPM Phase 2a Safety and Acceptability Study of a Vaginal Matrix Ring Containing Dapivirine in a Post-Menopausal Female Population

Additional Resources  Microbicides and HIV Prevention Research Glossary of Terms /attachments/GlossaryOfTerms.pdf