1 / 15

SOUTH AFRICAN MEDICAL RESEARCH COUNCIL

SOUTH AFRICAN MEDICAL RESEARCH COUNCIL. HIV PREVENTION RESEARCH UNIT. MICROBICIDE CLINICAL TRIALS IN SOUTH AFRICA. Global summary of the HIV and AIDS epidemic, 2006. Number of people living with HIV in 2006.

ivo
Download Presentation

SOUTH AFRICAN MEDICAL RESEARCH COUNCIL

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. SOUTH AFRICANMEDICAL RESEARCH COUNCIL HIV PREVENTION RESEARCH UNIT MICROBICIDE CLINICAL TRIALS IN SOUTH AFRICA

  2. Global summary of the HIV and AIDS epidemic, 2006 Number of people living with HIV in 2006 Total 39.5 million [34.1 – 47.1 million] Adults 37.2 million [32.1 – 44.5 million] Women 17.7 million [15.1 – 20.9 million] Children under 15 years 2.3 million [1.7 – 3.5 million] Total 4.3 million [3.6 – 6.6 million]Adults 3.8 million [3.2 – 5.7 million]Children under 15 years 530 000 [410 000 – 660 000] Total 2.9 million [2.5 – 3.5 million]Adults 2.6 million [2.2 – 3.0 million]Children under 15 years 380 000 [290 000 – 500 000] People newly infected with HIV in 2006 AIDS deaths in 2006 Ref: 2006 Epidemic Update

  3. A global view of HIV infection Ref: 2006 Epidemic Update

  4. SUB-SAHARAN AFRICA • Almost two thirds (63%) of all persons infected with HIV are living in Sub-Saharan Africa • South Africa – 5.5 million people living with HIV in 2005(HIV and Syphillis Seroprevalence Survey, South Africa) • HIV prevalence among pregnant women in South Africa = 30.2%(HIV and Syphillis Seroprevalence Survey, South Africa) • Face of HIV/AIDS in Africa = women • > 60% of infections among women • Women infected 5-10 years earlier • Young married women – infected at higher rate

  5. CURRENT HIV PREVENTION STRATEGIES • Monogamy • Condom use • Reduction in number of partners • Treatment of sexually transmitted diseases Some of these are often not feasible • Many women do not have the power to insist that their husbands or partners use condoms • Multiple sexual partnerships often serve as their only source of economic and social security • In many parts of the world, diagnosis and treatment for sexually transmitted infections (STI’s) are not available or stigmatized, a problem that is complicated by the fact that many of these infections are asymptomatic in women

  6. WHAT IS A MICROBICIDE? A microbicide is a substance that is designed to significantly reduce transmission of HIV and/or viral, bacterial, fungal or protozoan sexually transmitted pathogens when applied topically to genital mucosal surfaces

  7. WHAT IS A MICROBICIDE? Cont… • Why are microbicides needed? • The introduction of a microbicide could have a major public health impact. • A microbicide with 60% efficacy, introduced into 73 low-income countries, could avert 2.5 million HIV infections over 3 years in women, men and infants. • This would decrease the incidence rate of HIV with subsequent productivity benefits and large savings in health care costs • What’s special about microbicides? • they are “controllable” by either partner • could protect both partners (“bi-directional”) • some may prevent pregnancy • most would eventually be available over the counter • likely to be inexpensive • some may boost vagina’s natural defense mechanisms

  8. MICROBICIDES: DEVELOPMENT PIPELINE 5 in large-scale efficacy trials 14 in early safety trials Pre-clinical development (30 - 40 candidates) Early-stage concepts Adapted from Alliance for Microbicide Development, Microbicide Watch 2006

  9. MICROBICIDES: GLOBALPHASE IIB/III TRIALS  CARRAGUARD CELLULOSE SULFATE 2% & 0.5% PRO2000 BUFFERGEL & 0.5% PRO2000 C31G (SAVVY)    Burkina Faso Nigeria   Ghana Uganda Benin  India Tanzania   Malawi  Zambia    Zimbabwe   Philadelphia, USA South Africa   

  10. MICROBICIDES: CLINICAL TRIALS

  11. RANDOMIZED CONTROLLED TRIAL OF 6% CELLULOSE SULFATE GEL AND THE EFFECT ON VAGINAL HIV TRANSMISSION

  12. OBJECTIVES Primary Objective • To assess the effectiveness of 6% CS gel (3.5ml) compared to placebo gel (3.5ml) in preventing male to female vaginal transmission of HIV infection among women at high risk of HIV infection. Secondary Objective • To assess the effectiveness of 6% CS gel (3.5ml) compared to placebo gel (3.5ml) in preventing male-female transmission of gonococcal and Chlamydia infection.

  13. STUDY SITES AND ENROLLMENT TARGETS: India: 500 + 400 Uganda: 400 Benin Uganda Benin: 300 South Africa: 600 Total Enrollment Target: ± 2600

  14. STUDY BENEFITS & RISKS

  15. INTERIM ANALYSIS Benin Uganda South Africa India (2 sites) 1 333 Cellulose Sulphate Placebo 35 HIV Seroconversion Active Gel N = ? No data available Placebo N = ?

More Related