Microbicides: A new hope for HIV prevention 1 Salim S. Abdool Karim, MBChB, PhD Professor of...
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Microbicides: A new hope for HIV prevention 1 Salim S. Abdool Karim, MBChB, PhD Professor of Clinical Epidemiology, Columbia University Adjunct Professor
Microbicides: A new hope for HIV prevention 1 Salim S. Abdool
Karim, MBChB, PhD Professor of Clinical Epidemiology, Columbia
University Adjunct Professor of Medicine, Cornell University Pro
Vice-Chancellor (Research), University of KwaZulu-Natal HIV Center,
Columbia University, New York - 24 March 2011
Slide 2
Outline Brief review of the main CAPRISA 004 trial results A
new hope Three key lessons from CAPRISA 004 1.Adherence
2.Breakthrough infection clues 3.HSV-2 impact Conclusions
Slide 3
Age Group (Years) HIV Prevalence (N=1237) 1610.6% 17-1821.3%
19-2033.0% 21-2244.3% 23-2451.1% HIV prevalence in pregnant women
in rural Vulindlela, South Africa (2005-2008)
Slide 4
Source: Abdool Karim Q, Abdool Karim SS, Singh B, Short R,
Ngxongo S. AIDS 1992; 6: 1535-9 The urgent need for new prevention:
Age & gender profile of HIV infection: South Africa 0 49
Slide 5
Abdool Karim Q, et al. Clinical Infectious Diseases 2010;
50(S3):S122S129 5
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Preventing sexual spread of HIV: Existing accepted proven HIV
prevention strategies - ABCCC: A bstinence B ehaviour (Be faithful)
C ondoms (Male & Female) C ounselling and Testing C ircumcision
(Medical Male) Which of these are prevention tools for young women
in Africa?
Slide 7
Africa needs new HIV prevention technologies In South Africa
the epidemic continues to grow despite increased prevention efforts
Male condom distributed in 2002/3: 358 million Female condom
distribution doubled from 1,3 million in 2003 to 2,6 million in
2004 Combating the HIV epidemic is not only about scaling proven
prevention we also need new prevention technologies New HIV
prevention technologies are urgently needed in Africa, especially
those that empower women
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Slide 9
Stopped for futility Safe but not effective Increased HIV
infection Zena Stein publishes seminal article HIV prevention: the
need for methods women can use Kenya N-9 sponge trial FHI N-9 film
trial UNAIDS COL-1492 trial CONRAD CS trial FHI SAVVY trial
PopCouncil Carraguard trial HPTN PRO2000 & BufferGel trial 1 st
class: Surfactants eg. N9, SAVVY 2 nd class: Polymers eg. PRO2000,
Carraguard, Cellulose Sulfate (CS) 3 rd class: ARVs eg. Tenofovir
gel CAPRISA 004 Tenofovir gel trial MDP 0.5% PRO2000 trial 90 92 98
00 03 04 04 05 05 07 09 11 FHI CS Trial 2% PRO2000 Planned MTN003
VOICE Tenofovir gel & tablet trial FACTS 001 Tenofovir gel
trial CAPRISA 008 Tenofovir gel implementation trial Effective Past
and current microbicide trials IPM dapivarine ring
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10 BAT 24 coitally-related gel use Insert 1 gel up to 12 hours
Before sex, insert 1 gel as soon as possible within 12 hours After
sex, no more than Two doses in 24 hours HIVNET 012 nevirapine
regimen CAPRISA 004 tenofovir gel regimen asap 72 hrs 12 hrs Onset
of labour Delivery CAPRISA 004 assessed the safety and
effectiveness of 1% tenofovir gel
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Methods Proof of concept double-blinded, randomized, placebo-
controlled trial Enrolled high risk HIV uninfected women reporting
two coital acts in past 30 days known high risk populations from
pre-trial feasibility studies Endpoint driven trial (92 HIV
endpoints) HIV infection is primary safety & effectiveness
endpoint: HIV negative:2 negative rapid HIV tests HIV endpoint:PCR+
in 2 separate blood specimens Positive Western blot Intent-to-treat
analysis except for adherence analysis Intent-to-treat
analysis
Slide 13
CAPRISA Vulindlela Clinic KwaZulu-Natal Midlands CAPRISA
eThekwini Clinic Durban City Centre CAPRISA 004: Urban and Rural
sites
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Screening and Enrollment 196 excluded: 135 co-enrolled 50 in
other study
Impact of adherence on effectiveness of tenofovir gel 19 # HIVN
HIV incidence Effect p-value TFVPlacebo High adherers (>80% gel
adherence) 363364.29.3 54% 0.03 Intermediate adherers (50-80%
adherence) 201816.310.0 38% 0.29 Low adherers (