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Nyaradzo Mgodi ( MBChB, MMed) UZ-UCSF A nnual Research Day 17 April 2015

Characteristics of Women Enrolled into a Randomised Clinical Trial of Dapivirine Ring for HIV-1 Prevention. Nyaradzo Mgodi ( MBChB, MMed) UZ-UCSF A nnual Research Day 17 April 2015. Background.

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Nyaradzo Mgodi ( MBChB, MMed) UZ-UCSF A nnual Research Day 17 April 2015

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  1. Characteristics of Women Enrolled into a Randomised Clinical Trial of Dapivirine Ring for HIV-1 Prevention Nyaradzo Mgodi (MBChB, MMed) UZ-UCSF Annual Research Day 17 April 2015

  2. Background • Over half of the 24.7 million people living with HIV-1 infection in sub-Saharan Africa in 2013 were women . • Unprotected heterosexual intercourse is the leading mode of HIV-1 transmission amongst women in this region. • Randomized trials of the antiretroviral agent tenofovir, formulated as oral pills or a topical vaginal gel, demonstrated efficacy in diverse at-risk populations worldwide. • However, in two trials among young women at risk for HIV-1 (VOICE and FEM-PrEP), adherence to daily tenofovir-containing pills or vaginal gels was very low and HIV-1 prevention efficacy could not be assessed.

  3. Background • To quote Dr Hunidzarira from this morning “An HIV vaccine is the world’s best hope of ending HIV” • However, the world may be facing 20 million to 60 million new HIV infections in the 15 to 20 years it may take to develop and evaluate a vaccine that protects against HIV infection • In the interim, in order to protect women, development of potent, antiretroviral-based prevention products not requiring daily or coitally-dependent adherence is a priority. • Products like the Dapivirine Intra-vaginal ring

  4. Dapivirine Intra-vaginal Ring • Dapivirine is a non-nucleoside reverse transcriptase inhibitor • Flexible ring made of an elastic silicone material • Measures 56 mm (about 2 ½”) in diameter and 7.7 mm (3/4”) thick • Designed for 28-day use • International Partnership for Microbicides (IPM) providing both the placebo ring and the dapivirine ring for the study

  5. MTN-020 /ASPIRE A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Safety and Effectiveness Trial of a Vaginal Matrix Ring ContainingDapivirinefor thePreventionof HIV-1 Infection in Women (ClinicalTrials.govnumberNCT01617096). AStudy to Prevent Infection with a Ring for Extended Use

  6. MTN-020Objectives • Primary Objective – To determine the effectiveness and safety of dapivirine (25 mg) administered in a silicone elastomer vaginal matrix ring, when inserted once every 4 weeks, in preventing HIV-1 infection among healthy sexually active HIV-1 uninfected women • Secondary Objectives – To assess the acceptability of and adherence to the dapivirine vaginal ring, the frequency of drug resistance, and the relationship between drug concentrations and HIV-1 seroconversion

  7. MTN-020 Design Randomized, placebo-controlled, double-blind, phase III trial • • Sexually active HIV-1 uninfected women who are non-pregnant, contracepting, and between 18-45 years of age HIV-1 testing, risk reduction, contraceptive provision, safety monitoring, pregnancy testing, product provision, adherence counseling Ring worn for 4 weeks, replaced every 28-35 days All participants receive a comprehensive HIV-1 prevention package including risk-reduction, condoms, treatment of STIs, and partner testing and referral services • • •

  8. ASPIRE: 2,629 women, 15 sites, 4 countries Blantyre Lilongwe Malawi (272 women) – 10% Cape Town Durban (7 sites) Johannesburg South Africa (1,426 women) – 54 % Kampala Uganda (253 women) – 10% Harare/Chitungwiza (3 sites) Zimbabwe (678 women) - 26%

  9. Participant Characteristics

  10. Baseline Contraceptive Use

  11. STIs Detected at Screening

  12. Timeline Sept 2012 • Protocol implementation June 2014 • Completion of accrual July 2015 • Completion of follow-up visits Dec 2015 • ASPIRE results Q2/Q3 2016 • HOPE Implementation • To again quote - Dr Kangwende from this morning: • “We are Christians, we continue to

  13. MTN-025 Timeline ASPIRE results Dec 2015 HOPE (MTN-025)opens RA/IRB/EC informed Enrollment 6 months Former Participants contacted Up to 1-year open-label use of dapivirine ring Participants informed HOPE (MTN-025) approval and site activation National and community Stakeholders informed

  14. Thank you • Participants, partners and research communities • CAB Members • Chitungwiza City Health Department • ZNFPC • UZ-CHS • Staff at Seke South, Spilhaus, Zengeza CRSs • UZ-UCSF The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver  National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health.

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