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

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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

[email protected]