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