MTN-005 was a multi-site, randomized, open-label, two-arm, controlled trial of a non-medicated intravaginal ring. A vaginal ring delivery system for microbicides has the potential to minimize adherence problems found with the use of daily or coitally-dependent dosing regimens. This study evaluated the safety and adherence to intravaginal ring use in women in the U.S. and India Currently published data on the use of contraceptive or hormonal intravaginal rings among women in India is limited. The study population included healthy 18 to 45 year-old women who were HIV-uninfected, sexually-active, and using adequate contraception. Participants at two sites in the USA and a single site in India were randomized to one of two study arms: intravaginal ring use or no ring.
MTN-005 also examined the impact of 12 weeks of intravaginal ring use on vaginal flora. Studies have shown that the presence of H2O2-producing vaginal lactobacilli offers a protective effect against sexually transmitted infections. There were no previously published data on the impact of intravaginal ring use on quantitative measures of vaginal flora.
Results from this study are anticipated to contribute to the evaluation of safety of intravaginal rings as devices for sustained delivery of antiretroviral drugs for prevention of HIV in women. A manuscript reporting the primary results of Protocol MTN-005 is pending submission for publication.
US National Institutes of Health
Three-site, open label, two-arm, randomized controlled trial comparing study IVR to no IVR with randomization of 2:1 (IVR: No IVR)