The 4 th Decade of the HIV Epidemic: Midwest Regional Response September 17, 2013

1. 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

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

4. Microbicides

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

8. Vaginal applicator

9. Rectal applicator

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

14. Anal intercourse is a human behavior.

16. An act of unprotected anal intercourse is 10 to 20 timesmore likely to result in HIV transmission than an act of unprotected vaginal intercourse.

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)

19. MTN-017 • Real-time PK monitoring Slide courtesy Dr. Ian McGowan

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. Vaginal microbicide research CAPRISA 004

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

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

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 Monthly vaginal ring with Dapivirine – 2 trials Slide courtesy AVAC

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

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

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

35. Products that purr“MUST HAVE”

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

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

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

39. ringonit.org

40. Questions/comments?

41. Thank you jpickett@aidschicago.org