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Microbicide research in Africa:Microbicide research in Africa:Partnership in ActionPartnership in Action
Salim S. Abdool Karim, MD, PhD
Director: CAPRISAPro Vice-Chancellor (Research): University of KwaZulu-Natal
Professor in Clinical Epidemiology, Columbia UniversityAdjunct Professor of Medicine, Cornell University
OutlineOutline
Why the need for microbicides?
Past & current microbicide clinical trials
Why do the Women in Africa participate in microbicide trials
Partnership for microbicides: USA & Africa
Conclusion
The evolving HIV epidemic The evolving HIV epidemic in Africain Africa
Source: UNAIDS. 2006 Report on the global AIDS epidemic. UNAIDS, Geneva
Source: Abdool Karim Q, Abdool Karim SS, Singh B, Short R, Ngxongo S. AIDS 1992; 6: 1535-9
Age & gender distribution ofAge & gender distribution ofHIV infection in South AfricaHIV infection in South Africa
00
<9<9 10-1410-14
Pre
vale
nce
(%
)P
reva
len
ce (
%)
15-1915-19 20-2420-24 25-2925-29 30-3930-39 40-4940-49
22
44
66
88
1010
FemaleFemaleMaleMale
>49>49
Source: Data from South African Department of Health Antenatal Surveys. www.doh.gov.za/
0
5
10
15
20
25
30
35
1989 1991 1993 1995 1997 1999 2001 2003 2005 2007
HIV
Pre
vale
nce
(%
)H
IV P
reva
len
ce (
%)
The HIV epidemic in South AfricaThe HIV epidemic in South Africa
HIV prevalence in pregnant women attending public antenatal clinics in South Africa 1989-2006
Africa needs newAfrica needs newHIV prevention technologiesHIV 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
BARRIER METHODS
(Male & Female Condoms)
MTCT&
PEP
VCT
BEHAVIOURAL CHANGE
VACCINES
PrEP
MICROBICIDES
ANTI-RETROVIRAL
THERAPY FOR PREVENTION
HIV PreventionMethods
MALECIRCUMCISION
HARMREDUCTION
Underinvestigation
Proven HIVprevention methods
Carraguard C31G (SAVVY) Cellulose sulphate PRO 2000 (ph III) BufferGel®/ PRO 2000 (ph IIb) Tenofovir Gel (ph IIb)
Microbicide trials in Africa Microbicide trials in Africa
Past & Current Microbicide Clinical TrialsPast & Current Microbicide Clinical Trials
Stopped for futility Safe but not effective Increased HIV infection
Zena Stein publishes
seminal article “HIV
prevention: the need for
methods women can use”
KenyaN-9 sponge
trial
FHIN-9 film trial
UNAIDSCOL-1492
trial
CONRADCS trial
FHI SAVVY trial
PopCouncilCarraguard trial
HPTN PRO2000 &
BufferGel trial
1st class:Surfactants
eg. N9, SAVVY
2nd class:Polymers
eg. PRO2000,Carraguard,
Cellulose Sulfate (CS)
3rd class:ARVs
eg. Tenofovir gel,Dapivirine gel/ring
4th class:Co-receptor
Blockers
eg. CD4 blocker,CCR5 Blockers
CAPRISATenofovir gel trial
MTNTenofovir
gel & tablet trial
MDP 0.5%PRO2000
trial
‘‘90 ‘92 ’98 ’00 ‘03 ‘04 ‘04 ’05 ’05 ’07 ’09 90 ‘92 ’98 ’00 ‘03 ‘04 ‘04 ’05 ’05 ’07 ’09 ‘10 ‘10
IPMDapivirinegel & ring
trial
FHI CSTrial
2% PRO2000
Planned
Women in Africa actively participate in microbicide research…
… microbicides offer the Women of Africa a prevention method that they can use and
control to reduce their risk of HIV infection
Why do Women in Africa participate in microbicide trials…
Why do women in Africa participate in Why do women in Africa participate in microbicide trials…microbicide trials…
……hope in new generation antiretroviral hope in new generation antiretroviral microbicides like Tenofovir & Dapivirinemicrobicides like Tenofovir & Dapivirine
Partnership for microbicides:Partnership for microbicides:
Secretary Leavitt visits US government funded tenofovir Secretary Leavitt visits US government funded tenofovir microbicide trial clinic in rural Vulindlela, South Africamicrobicide trial clinic in rural Vulindlela, South Africa
Secretary Leavitt, Chief Nkosi, Sister Zuma & Dr Abdool Karim light the Secretary Leavitt, Chief Nkosi, Sister Zuma & Dr Abdool Karim light the AIDS candle in memory of all Vulindlela women who succumbed to AIDSAIDS candle in memory of all Vulindlela women who succumbed to AIDS
ConclusionConclusion Need a women-controlled HIV prevention method if
we are to alter the course of the HIV epidemic in Africa
Women of Africa want to actively participate in microbicide trials
First antiretroviral microbicide effectiveness trial is underway as a joint project funded by both the United States and South African governments
Two large effectiveness trials planned by MTN and IPM
We can achieve the goal of a safe & effective microbicide through working together in partnership