Microbicide research in Africa: Partnership in Action Salim S. Abdool Karim, MD, PhD Director: CAPRISA Pro Vice-Chancellor (Research): University of KwaZulu-Natal Professor in Clinical Epidemiology, Columbia University Adjunct Professor of Medicine, Cornell University

Outline  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 in Africa Source: UNAIDS Report on the global AIDS epidemic. UNAIDS, Geneva

Source: Abdool Karim Q, Abdool Karim SS, Singh B, Short R, Ngxongo S. AIDS 1992; 6: Age & gender distribution of HIV infection in South Africa 0 < Prevalence (%) Female Male >49

Source: Data from South African Department of Health Antenatal Surveys HIV Prevalence (%) The HIV epidemic in South Africa HIV prevalence in pregnant women attending public antenatal clinics in South Africa

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

BARRIER METHODS (Male & Female Condoms) MTCT & PEP VCT BEHAVIOURAL CHANGE VACCINES PrEP MICROBICIDES ANTI- RETROVIRAL THERAPY FOR PREVENTION HIV Prevention Methods MALE CIRCUMCISION HARM REDUCTION Under investigation Proven HIV prevention methods

 Carraguard  C31G (SAVVY)  Cellulose sulphate PRO 2000 (ph III)  BufferGel®/ PRO 2000 (ph IIb)  Tenofovir Gel (ph IIb) Microbicide trials in Africa                

Past & 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” 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, Dapivirine gel/ring 4 th class: Co-receptor Blockers eg. CD4 blocker, CCR5 Blockers CAPRISA Tenofovir gel trial MTN Tenofovir gel & tablet trial MDP 0.5% PRO2000 trial ‘90 ‘92 ’98 ’00 ‘03 ‘04 ‘04 ’05 ’05 ’07 ’09 ‘10 IPM Dapivirine gel & ring trial FHI CS Trial 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 microbicide trials… …hope in new generation antiretroviral microbicides like Tenofovir & Dapivirine

Partnership for microbicides: Secretary Leavitt visits US government funded tenofovir microbicide trial clinic in rural Vulindlela, South Africa Secretary Leavitt, Chief Nkosi, Sister Zuma & Dr Abdool Karim light the AIDS candle in memory of all Vulindlela women who succumbed to AIDS

Conclusion  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