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New Findings on the Future of Sex

New Findings on the Future of Sex. The Latest in HIV Prevention Technology Latino HIV/STD Network April 13, 2011 Jim Pickett Director Prevention Advocacy and Gay Men’s Health AIDS Foundation of Chicago. Today. Who is IRMA? State of prevention

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New Findings on the Future of Sex

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  1. New Findings on the Future of Sex The Latest in HIV Prevention Technology Latino HIV/STD Network April 13, 2011 Jim Pickett Director Prevention Advocacy and Gay Men’s Health AIDS Foundation of Chicago

  2. Today Who is IRMA? State of prevention CAPRISA 004 iPrEx Rectal microbicides Implications

  3. Who is IRMA? • Mission: support development of safe, effective, acceptable, and accessible rectal microbicides for all that need them • 1000+ advocates, scientists, funders, policymakers from 6 continents – S. America/Latin America and Nigeria chapters AFC secretariat

  4. rectalmicrobicides.org Global context

  5. Condoms work. So why do we need new strategies to halt the sexual transmission of HIV?

  6. Here are some reasons for new strategies Source: Roger Tatoud PhD, Senior Programme Manager, International HIV Clinical Trials Research Mgmt Office, Imperial College London & IRMA Steering Committee Member

  7. Pleasure

  8. Prior to exposure Point of transmission Treatment What if we had a complete prevention tool kit? Improved ARV therapy Treatment for opportunistic infections Basic care/nutrition Prevention for positives Education & rights-focused behaviour change Therapeutic vaccines • Rights-focused behaviourchange • Voluntary counselling and testing • STI screening and treatment • Male medical circumcision • Preventive Vaccines • Pre-exposure prophylaxis (PrEP) • Male and female condoms and lube • ARV treatment to prevent vertical transmission (PMTCT) • Clean injecting equipment • Post-exposure prophylaxis (PEP) • Vaginal and rectal microbicides ARV = antiretroviral

  9. The prevention landscape has forever changed

  10. 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 • Formulated as a lubricant, gel, film, or vaginal ring • A rectal microbicide (RM) might be delivered via suppository, douche, or an enema – in addition to a lube Microbicides are still in development they are not available yet!

  11. How would a microbicide work?

  12. Vaginal ring Gel, lubricant ? Suppository Rectal Applicator Film Enema Examples of how a microbicide might be delivered

  13. CAPRISA 004

  14. VOICE/MTN 003

  15. VOICE/MTN 003 • Study • oral PrEP (once-daily tenofivr) • oral PrEP (once-daily Truvada) • topical tenofovir gel (once-daily application) • placebo pill (once-daily) • placebo gel (once-daily application) • Participants: 5,000 women • Countries: South Africa, Uganda, Zimbabwe • Results 2013

  16. Other follow-up studies • CAPRISA 008 • Phase IIIb – same communities as CAPRISA 004 • Open label – CAP 004 participants, research naive • Implementation • Randomized between family planning, CAPRISA clinic • FACTS 001 • Follow on Africa Consortium for Tenofovir Studies • Phase III – 3,150 women 16 – 30, RSA and Kenya • Filling critical gap 16, 17 y.o. • Same dosing regimen CAP 004

  17. Pre-exposure prophylaxis (PrEP)

  18. Following slides courtesy Bob Grant

  19. * * n= 225

  20. iPrEx – U.S. youth Mean age Boston and San Francisco >30. Boston closer to 40

  21. *Only about half the men took their pills

  22. Open label access to Truvada • All participants invited • Choice to take pill, or not • 72 weeks • Starting soon

  23. Acceptability of rectal microbicides • iPrEx – Only 50% of men took their pills regularly, if at all • An ARV-based prevention option based on a lubricant or an enema could be more acceptable to these men • Two Phase I studies completed • MTN 007 Phase I underway • Phase II down the road • Buffet approach!

  24. PrEP – our kind of town

  25. Following slides courtesy Sybil Hosek

  26. Project PrEPare [ATN 082] Exploring the Acceptability and Feasibility of PrEP Young MSM - Chicago

  27. What did they want to find out? • Acceptability and feasibility • Are young gay men willing to join and stay in this kind of PrEP study? What makes them stay? • Is it possible to do this with a large group of young men? What are the possible barriers: • adherence • acting riskier because they feel they are protected • They were not testing to see if the drug worked (efficacy) • Results forthcoming Project PrEPare [ATN 082]

  28. What was involved? • 9 clinic visits over approximately 8 months, 2-day weekend intervention (Many Men Many Voices – 3MV) • Participants randomly assigned to one of three study arms: • 1) Once-daily Truvada • 2) Placebo (sugar pill) • 3) No pill Project PrEPare [ATN 082]

  29. Who did they enroll? • 68 participants enrolled • 10 discontinued prior to randomization • Average age 20 (range 18-22) • 48% Black, 42% Latino, 10% White Project PrEPare [ATN 082]

  30. Where did participants come from? Project PrEPare [ATN 082]

  31. Rectal microbicides

  32. RM research activities • Baseline studies • What normally happens during AI? • Formulation studies • How will different chemicals and substances be put together to make a safe, effective RM? • Distribution studies • Where do RMs need to go?

  33. RM research activities • Acceptability & behavioural studies • What kinds of products would people use? • Who is having AI? • Pre-clinical/basic science • developing and testing products in labs and in animal studies • Clinical trials – safety and efficacy • Are these RMs safe? Do they work?

  34. RM research activities Source: From Promise to Product: Advancing Rectal Microbicide Research and Advocacy

  35. The RM pipeline is flowing • RMP 01 – UC-781 • MTN 006 – tenofovir • MTN 007 – modified tenofovir , underway • Project Gel underway • MTN 017 • 36 U.S. • 18 U.S. • 60 U.S., 3 sites • 120/42 U.S., Puerto Rico • 150 – 200 Peru, RSA, Thailand, U.S.

  36. Boston, Pittsburgh, Birmingham Almost complete Slide courtesy of Ian McGowan MD PhD

  37. Project Gel [Microbicide Safety and Acceptability in Young Men] Pittsburgh, Boston, Puerto Rico Stage 1B 3 month Acceptability & Adherence study with placebo gel 120 MSM RAI in last 3 months STI negative Stage 2 Phase 1 tenofovir rectal safety study 42 MSM 80% adherence in Stage 1B Stage 1A Screening 240 MSM Consensual RAI in last month URAI in last year McGowan & Carballo-Dieguez

  38. Populations for RM studies

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