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Jim Pickett, AFC/IRMA Los Angeles Biomedical Forum May 31, 2013

The Present and Future of Microbicides. Jim Pickett, AFC/IRMA Los Angeles Biomedical Forum May 31, 2013. Our time together…. Microbicides What are they? Vaginal microbicide research Rectal microbicide research IRMA Who is she? Rectal microbicide advocacy. Microbicides.

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Jim Pickett, AFC/IRMA Los Angeles Biomedical Forum May 31, 2013

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  1. The Present and Future of Microbicides Jim Pickett, AFC/IRMALos Angeles Biomedical Forum May 31, 2013

  2. Our time together… • Microbicides • What are they? • Vaginal microbicide research • Rectal microbicide research • IRMA • Who is she? • Rectal microbicide advocacy

  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 STI pathogens • Ideally would have a contraceptive version, and another to allow for pregnancy – ARV/non-ARV (MPTs) • 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!

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

  6. Vaginal microbicide research CAPRISA 004

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

  8. 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 CROI

  9. 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

  10. Anal intercourse is a human behavior.

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

  12. Rectal microbicide research • RMP 01 – UC-781 • MTN 006 – tenofovir • MTN 007 – modified tenofovir • Project Gel, CHARM SOON MTN 017 • 36 men/women U.S. • 18 m/w U.S. • 65 m/w U.S. • 186 Peru, RSA, Thailand, U.S., PR (gay, MSM, TG women)

  13. NICHD R01: Ian McGowan & Alex Carballo-Dieguez

  14. RM Safety, Acceptability /Young Men Stage 1B 3 month Acceptability & Adherence study with placebo gel 120 MSM RAI in last 3 months STI negative Stage 1A Screening 240 MSM Consensual RAI in last month URAI in last year Stage 2 Phase 1 Tenofovir rectal safety study 24 MSM R01 HD059533 Slide courtesy Dr. Ian McGowan

  15. CHARM Program • Combination HIV Antiretroviral Rectal Microbicide Program • Development of rectal specific ARV microbicides • Humanized mouse model • Phase 1 studies • Tenofovir • Maraviroc • Tenofovir & Maraviroc Slide courtesy Dr. Ian McGowan, pic from the IRMA collection

  16. CHARM 01 • Phase 1 rectal safety study • Tenofovir 1% gel • Original formulation (3,111) • Reduced glycerin formulation (846) • Rectal specific formulation (479) • Endpoints • Safety, • Acceptability, • PK/PD • N = 18 • Sites • Pittsburgh • UCLA • Q1 2013 Slide courtesy Dr. Ian McGowan

  17. CHARM 02 • Phase 1 rectal safety study • Safety in the presence or absence of simulated coitus • Endpoints • Safety • PK • Product distribution • N = 9 • Sites • Johns Hopkins • Q1 2013 Slide courtesy Dr. Ian McGowan

  18. CHARM 03 • Phase 1 rectal safety study • Maraviroc • CCR5 antagonist (Selzentry®) • Study products • Maraviroc 0.1% • Maraviroc 1.0 % • Maraviroc + tenofovir • Endpoints • Safety, • Acceptability, • PK/PD • N = 24 • Sites • Pittsburgh • UCLA • Johns Hopkins • Q1 2014 Slide courtesy Dr. Ian McGowan

  19. MTN-017 – Any day now… Slide courtesy Dr. Ian McGowan

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

  21. Who is IRMA?

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

  23. 1200+ advocates, scientists, funders, policymakers from 6 continents AIDS Foundation of Chicago is the IRMA secretariat

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

  25. Focused projects in Africa, S. America

  26. Linda-Gail Bekker, Desmond Tutu HIV Foundation

  27. YouTubetinyurl.com/RectalRevEnglish tinyurl.com/RectalRevSpanish tinyurl.com/RectalRevThai

  28. rectalmicrobicides.org

  29. Monograph being published by RAND – coming to you soon electronically, and featuring a forward by Archbishop Desmond Tutu. Visit www.mappingpathways.blogspot.com

  30. Thanks to our supporters • AIDS Foundation of Chicago • amfAR – The Foundation for AIDS Research • Broadway CARES /Equity Fights AIDS • Elton John AIDS Foundation • New Venture Fund • NIH Office of AIDS Research • AVAC • MAC AIDS Foundation • Microbicide Trials Network • Population Council • Individuals - like my partner

  31. Thank you xxoo

  32. Questions/comments?

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