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The 4th Decade of the HIV Epidemic: Midwest Regional ResponseSeptember 17, 2013with Jim Pickett, AFC/IRMA
The Bottom Line on
Rectal and Vaginal Microbicide
Research
Today
• Brief update on rectal and vaginal microbicide research
• Chgo-based global microbicide action–IRMA
Microbicides
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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!
McGowan I, Biologicals, 2006Slide courtesy Dr. Ian McGowan
How a microbicide works
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Vaginal applicator
Rectal applicator
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What is the first word or words that come to your mind when you think about PrEP?
Honesty please
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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.
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The science
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)
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MTN-017
8 weeks 8 weeks 8 weeksGel Daily
Gel With Sex
OralTruvada
Gel With Sex
Gel Daily
OralTruvada
OralTruvada
Gel With Sex
Gel Daily
Slide courtesy Dr. Ian McGowan
Real-time PK monitoring
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To enjoy (the gel)
first you need
to use it
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
CAPRISA 004
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Vaginal microbicide research
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
80% + compliance = 54% efficacy
The trial achieved a
95% retention rate
Vaginal microbicide research
• CAPRISA 004 – YAY
– CAPRISA 008 • Implementation study
underway• Effectiveness/sustainability in
rural and urban clinics• HIV-negative CAPRISA 004
participants
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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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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
Our kinda town…
• Chicago-based action– Who is IRMA?
4 people, 4 agencies, 2 countries
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IRMA, b.2005
1200+ advocates,
scientists, funders, policymakers from
6 continents
31AIDS Foundation of Chicago is the IRMA secretariat
Mission: support development of safe, effective,
acceptable, and accessible
rectal microbicides for all that need them
32AIDS Foundation of Chicago is the IRMA secretariat
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Highly active moderated
listserv Website
Blog, Facebook,
Twitter, YouTube
Global teleconferences
Materials, presentations
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RM advocacy and education
Lubricant safety/access
Engage w/ clinical
research
Anal health, anal sex
Funding, civil society support
Engage w/ science and community
Products that purr “MUST HAVE”
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tinyurl.com/rectalvid in English, Spanish, Thai
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tinyurl.com/rectalvid in English, Spanish, Thai
38tinyurl.com/rectalvid in English, Spanish, Thai
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Questions/comments?
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Thank you
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