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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
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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
4
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
7
8
Vaginal applicator
Rectal applicator
10
What is the first word or words that come to your mind when you think about PrEP?
Honesty please
13
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.
17
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)
18
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
20
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
23
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
25
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
27
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
30
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
33
Highly active moderated
listserv Website
Blog, Facebook,
Twitter, YouTube
Global teleconferences
Materials, presentations
34
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”
36
tinyurl.com/rectalvid in English, Spanish, Thai
37
tinyurl.com/rectalvid in English, Spanish, Thai
38tinyurl.com/rectalvid in English, Spanish, Thai
40
Questions/comments?
41
Thank you
jpickett@aidschicago.org
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