The Bottom Line on Rectal and Vaginal Microbicide Research The 4th Decade of the HIV Epidemic: Midwest Regional Response September 17, 2013 with Jim Pickett, AFC/IRMA.
Download ReportTranscript The Bottom Line on Rectal and Vaginal Microbicide Research The 4th Decade of the HIV Epidemic: Midwest Regional Response September 17, 2013 with Jim Pickett, AFC/IRMA.
The Bottom Line on Rectal and Vaginal Microbicide Research The 4th Decade of the HIV Epidemic: Midwest Regional Response September 17, 2013 with Jim Pickett, AFC/IRMA Today • Brief update on rectal and vaginal microbicide research • Chgo-based global microbicide action –IRMA 3 Microbicides 4 What is a microbicide? • A product applied topically in the vagina or the rectum that can offer protection against HIV and, ideally, other sexually transmitted infections • Ideally would have a contraceptive version, and another to allow for pregnancy – ARV/non-ARV • Formulated as a gel/lubricant, film, or vaginal ring • A rectal microbicide might be delivered via gel/lubricant, douche/enema, or … Microbicides are still in development they are not available yet! How a microbicide works McGowan I, Biologicals, 2006 Slide courtesy Dr. Ian McGowan 7 Vaginal applicator 8 Rectal applicator 10 Honesty please What is the first word or words that come to your mind when you think about PrEP? 13 Anal intercourse is a human behavior. An act of unprotected anal intercourse is 10 to 20 times more likely to result in HIV transmission than an act of unprotected vaginal intercourse. The science 17 Rectal microbicide research • RMP 01 – UC-781 • 36 U.S. (m/f) • MTN 006 – tenofovir • 18 U.S. (m/f) • MTN 007 – modified tenofovir • 65 U.S. (m/f) • Project Gel underway • 120 U.S., PR (m) Any day now! MTN 017 • 186 Peru, RSA, Thailand, U.S., PR (gay, msm, tgw) 18 MTN-017 8 weeks Gel Daily 8 weeks Gel With Sex 8 weeks Oral Truvada Gel With Sex Gel Daily Oral Truvada Oral Truvada Gel With Sex Gel Daily Real-time PK monitoring Slide courtesy Dr. Ian McGowan 20 CHARM Program • Combination HIV Antiretroviral Rectal Microbicide Program • Development of rectal specific ARV microbicides • Humanized mouse model • Phase 1 studies – Tenofovir (rectal specific) – Maraviroc (rectal specific) – Tenofovir & Maraviroc (rectal specific) Slide courtesy Dr. Ian McGowan Vaginal microbicide research CAPRISA 004 23 South Africa 2 sites in KwaZulu-Natal Phase IIB - 889 HIV- women, 18 – 40 Enrolled May 2007 – Jan. 2009 Vaginally formulated tenofovir gel Results July 20, 2010 – AIDS 2010 Vaginal microbicide research • CAPRISA 004 – YAY – CAPRISA 008 • Implementation study underway • Effectiveness/sustainability in rural and urban clinics • HIV-negative CAPRISA 004 participants 25 Vaginal microbicide research • VOICE • Phase 2B, randomized, double-blind, placebo-controlled, 5-arm trial • 5029 women in trial – Uganda, South Africa and Zimbabwe • Studied daily use of following : – Vaginal tenofovir 1% gel – Oral tenofovir – Oral Truvada • Results announced March 2013 26 27 The Big 3 – Effectiveness Trials • • • • Phase III trial of tenofovir gel BAT24 dosing – hope to confirm CAPRISA 004 2600 women, age 18-30, SA 10 sites Oct 2011 ~ mid 2014 Monthly vaginal ring with Dapivirine – 2 trials IPM 023/The Ring Study ASPIRE/MTN 027, P III Phase III 1650 women South Africa, Rwanda Apr 2012 ~ mid 2015 • Phase III • 3500 women • Malawi, SA, Uganda, Zambia, Zimbabwe • July 2012 ~ end 2014 • • • • Slide courtesy AVAC Our kinda town… • Chicago-based action – Who is IRMA? IRMA, b.2005 4 people, 4 agencies, 2 countries 30 1200+ advocates, scientists, funders, policymakers from 6 continents AIDS Foundation of Chicago is the IRMA secretariat 31 Mission: support development of safe, effective, acceptable, and accessible rectal microbicides for all that need them AIDS Foundation of Chicago is the IRMA secretariat 32 Highly active moderated listserv Website Materials, presentations Global teleconferences Blog, Facebook, Twitter, YouTube 33 RM advocacy and education Engage w/ science and community Lubricant safety/access Engage w/ clinical research Funding, civil society support Anal health, anal sex 34 Products that purr “MUST HAVE” tinyurl.com/rectalvid in English, Spanish, Thai 36 tinyurl.com/rectalvid in English, Spanish, Thai 37 tinyurl.com/rectalvid in English, Spanish, Thai 38 ringonit.org Questions/comments? 40 Thank you [email protected] 41