The 4 th Decade of the HIV Epidemic: Midwest Regional Response September 17, 2013
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The Bottom Line on Rectal and Vaginal Microbicide Research. The 4 th Decade of the HIV Epidemic: Midwest Regional Response September 17, 2013 with Jim Pickett, AFC/IRMA. Today. Brief update on rectal and vaginal microbicide research Chgo -based global microbicide action IRMA. - PowerPoint PPT Presentation
Transcript of The 4 th Decade of the HIV Epidemic: Midwest Regional Response September 17, 2013
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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
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 infectionsIdeally would have a contraceptive version, and another to allow for pregnancy ARV/non-ARVFormulated 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!
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Vaginal applicator8
McGowan I, Biologicals, 2006
Slide courtesy Dr. Ian McGowan How a microbicide works
Rectal applicator
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Jim and/or Jessica11
Jim and/or Jessica12What is the first word or words that come to your mind when you think about PrEP?
Honesty please13
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Anal intercourse is a human behavior.
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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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17The science
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Rectal microbicide researchRMP 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)
1818 MTN-0178 weeks8 weeks8 weeksGel DailyGel With SexOralTruvadaGel With SexGel DailyOralTruvadaOralTruvadaGel With SexGel Daily
Slide courtesy Dr. Ian McGowan
Real-time PK monitoring
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To enjoy (the gel) first you need to use it20 CHARM ProgramCombination HIV Antiretroviral Rectal Microbicide ProgramDevelopment of rectal specific ARV microbicidesHumanized mouse modelPhase 1 studiesTenofovir (rectal specific)Maraviroc (rectal specific)Tenofovir & Maraviroc (rectal specific)
Slide courtesy Dr. Ian McGowan
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CAPRISA 004
23 Vaginal microbicide research
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Vaginal microbicide researchCAPRISA 004 YAY
CAPRISA 008 Implementation study underwayEffectiveness/sustainability in rural and urban clinicsHIV-negative CAPRISA 004 participants
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Vaginal microbicide researchVOICEPhase 2B, randomized, double-blind, placebo-controlled, 5-arm trial5029 women in trial Uganda, South Africa and ZimbabweStudied daily use of following :Vaginal tenofovir 1% gel Oral tenofovirOral TruvadaResults announced March 2013
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27The Big 3 Effectiveness TrialsPhase III trial of tenofovir gelBAT24 dosing hope to confirm CAPRISA 0042600 women, age 18-30, SA 10 sitesOct 2011 ~ mid 2014
IPM 023/The Ring StudyPhase III1650 womenSouth Africa, RwandaApr 2012 ~ mid 2015ASPIRE/MTN 027, P IIIPhase III3500 womenMalawi, SA, Uganda, Zambia, ZimbabweJuly 2012 ~ end 2014Monthly vaginal ring with Dapivirine 2 trialsSlide courtesy AVAC
Our kinda townChicago-based action Who is IRMA?29
4 people, 4 agencies, 2 countries30 IRMA, b.200530
1200+ advocates, scientists, funders, policymakers from 6 continents 31
AIDS Foundation of Chicago is the IRMA secretariat
31Mission: support development of safe, effective, acceptable, and accessible rectal microbicides for all that need them
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AIDS Foundation of Chicago is the IRMA secretariat
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Products that purr MUST HAVE
36tinyurl.com/rectalvid in English, Spanish, Thai
3637tinyurl.com/rectalvid in English, Spanish, Thai
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tinyurl.com/rectalvid in English, Spanish, Thai38
ringonit.org
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Questions/comments?
41 Thank you
