1. The 4 th 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

2. Today Brief update on rectal and vaginal microbicide research Chgo-based global microbicide action – IRMA

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4. Microbicides 4

5. 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!

6. McGowan I, Biologicals, 2006 Slide courtesy Dr. Ian McGowan How a microbicide works

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8. 8 Vaginal applicator

9. Rectal applicator

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13. What is the first word or words that come to your mind when you think about PrEP? Honesty please 13

14. Anal intercourse is a human behavior.

16. 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.

17. 17 The science

18. Rectal microbicide research RMP 01 – UC-781 MTN 006 – tenofovir MTN 007 – modified tenofovir Project Gel underway Any day now! MTN 017 36 U.S. (m/f) 18 U.S. (m/f) 65 U.S. (m/f) 120 U.S., PR (m) 186 Peru, RSA, Thailand, U.S., PR (gay, msm, tgw) 18

19. MTN-017 8 weeks Gel Daily Gel With Sex Oral Truvada Gel With Sex Gel Daily Oral Truvada Oral Truvada Gel With Sex Gel Daily Slide courtesy Dr. Ian McGowan Real-time PK monitoring

20. 20 To enjoy (the gel) first you need to use it

21. 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

23. CAPRISA 004 23 Vaginal microbicide research

24. 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

25. Vaginal microbicide research CAPRISA 004 – YAY – CAPRISA 008 Implementation study underway Effectiveness/sustainability in rural and urban clinics HIV-negative CAPRISA 004 participants 25

26. 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

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28. 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 IPM 023/The Ring Study Phase III 1650 women South Africa, Rwanda Apr 2012 ~ mid 2015 ASPIRE/MTN 027, P III Phase III 3500 women Malawi, SA, Uganda, Zambia, Zimbabwe July 2012 ~ end 2014 Monthly vaginal ring with Dapivirine – 2 trials Slide courtesy AVAC

29. Our kinda town… Chicago-based action – Who is IRMA?

30. 4 people, 4 agencies, 2 countries 30 IRMA, b.2005

31. 1200+ advocates, scientists, funders, policymakers from 6 continents 31 AIDS Foundation of Chicago is the IRMA secretariat

32. Mission: support development of safe, effective, acceptable, and accessible rectal microbicides for all that need them 32 AIDS Foundation of Chicago is the IRMA secretariat

33. 33 Highly active moderated listserv Website Blog, Facebook, Twitter, YouTube Global teleconferences Materials, presentations

34. 34 RM advocacy and education Lubricant safety/access Engage w/ clinical research Anal health, anal sex Funding, civil society support Engage w/ science and community

35. Products that purr “MUST HAVE”

36. 36 tinyurl.com/rectalvid in English, Spanish, Thai

37. 37 tinyurl.com/rectalvid in English, Spanish, Thai

38. 38 tinyurl.com/rectalvid in English, Spanish, Thai

39. ringonit.org

40. 40 Questions/comments?

41. 41 Thank you jpickett@aidschicago.org