The Bottom Line on Rectal and Vaginal Microbicide Research The 4th Decade of the HIV Epidemic: Midwest Regional Response September 17, 2013 with Jim Pickett, AFC/IRMA.

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Transcript The Bottom Line on Rectal and Vaginal Microbicide Research The 4th Decade of the HIV Epidemic: Midwest Regional Response September 17, 2013 with Jim Pickett, AFC/IRMA.

The Bottom Line
on
Rectal and Vaginal
Microbicide
Research
The 4th 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
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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!
How a microbicide works
McGowan I, Biologicals, 2006
Slide courtesy Dr. Ian McGowan
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Vaginal applicator
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Rectal applicator
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Honesty please
What is the first word or
words that come to your
mind when you think
about PrEP?
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Anal intercourse
is a human behavior.
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.
The science
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Rectal microbicide research
• RMP 01 – UC-781
• 36 U.S. (m/f)
• MTN 006 – tenofovir • 18 U.S. (m/f)
• MTN 007 – modified
tenofovir
• 65 U.S. (m/f)
• Project Gel underway • 120 U.S., PR (m)
Any day now! MTN 017 • 186 Peru, RSA, Thailand,
U.S., PR (gay, msm, tgw)
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MTN-017
8 weeks
Gel
Daily
8 weeks
Gel
With Sex
8 weeks
Oral
Truvada
Gel
With Sex
Gel
Daily
Oral
Truvada
Oral
Truvada
Gel
With Sex
Gel
Daily
Real-time PK monitoring
Slide courtesy Dr. Ian McGowan
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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
Vaginal microbicide research
CAPRISA 004
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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
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
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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
Monthly vaginal ring with Dapivirine – 2 trials
IPM 023/The Ring Study
ASPIRE/MTN 027, P III
Phase III
1650 women
South Africa, Rwanda
Apr 2012 ~ mid 2015
• Phase III
• 3500 women
• Malawi, SA, Uganda,
Zambia, Zimbabwe
• July 2012 ~ end 2014
•
•
•
•
Slide courtesy AVAC
Our kinda town…
• Chicago-based action
–
Who is IRMA?
IRMA, b.2005
4 people, 4 agencies, 2 countries
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1200+
advocates,
scientists, funders,
policymakers from
6 continents
AIDS Foundation of Chicago is the IRMA secretariat
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Mission: support
development of
safe, effective,
acceptable, and
accessible
rectal microbicides
for all that need them
AIDS Foundation of Chicago is the IRMA secretariat
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Highly active
moderated
listserv
Website
Materials,
presentations
Global
teleconferences
Blog,
Facebook,
Twitter,
YouTube
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RM advocacy
and education
Engage w/
science and
community
Lubricant
safety/access
Engage w/
clinical
research
Funding, civil
society
support
Anal health, anal sex
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Products that purr “MUST HAVE”
tinyurl.com/rectalvid in English, Spanish, Thai
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tinyurl.com/rectalvid in English, Spanish, Thai
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tinyurl.com/rectalvid in English, Spanish, Thai
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ringonit.org
Questions/comments?
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Thank
you
[email protected]
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