18 February 2008
The Minister of Health, Dr Manto Tshabalala-Msimang received a presentation on two microbicide studies from principal investigators in Pretoria today. The meeting was also attended by the representatives of the Medical Research Council, Medicine Control Council, Clinical Trials Committee and the National Health Research Ethics Committee.
The findings of Phase 3 clinical trial of the Population Council, candidate microbicide Carraguard was presented at the meeting. The Carraguard study was conducted in Gugulethu (Cape Town), Soshanguve (Pretoria) and Isipingo (Durban).
The findings indicate that Carraguard was not effective in preventing male-to-female HIV transmission during vaginal intercourse.
The Minister also received a presentation on the Microbicides Development Programme (MDP) currently studying the candidate microbicide PRO 2000/5 sponsored by UK Medical Research Council. The MDP trial is conducted at kwaHlabisa, Isipingo, Tongaat and Verulam in KwaZulu-Natal and Orange Farm and Soweto in Gauteng.
There are three arms to the MDP trial: 2% PRO 2000/5, 0,5% PRO 2000/5 and placebo.
The researchers have requested discontinuation of the 2% arm of the study while the 0.5% should continue with placebo as a control group. 2% PRO 2000/5 gel arm is being discontinued because it is unlikely to show benefit.
There was general agreement at the meeting that there is limited understanding of the epidemiology and biology of HIV transmission and thus limiting the possibility of success for most products that are being tested for prevention of HIV. There is a need to better understand the factors driving the high prevalence of HIV in Southern Africa compared to other regions of the world.
"The continued inability of these products to deliver the desired outcomes poses a serious challenge. While there is an urgent need for innovation, how do we maintain the public confidence in the possibility for success amid the many setbacks affecting HIV prevention research," said Minister Tshabalala-Msimang.
Minister Tshabalala-Msimang emphasized the need for strengthening of controls including the evaluation of pre-clinical development of the products and results from phase one and two trials that may have effect on phase-three human clinical trial on efficacy. This include interrogation of all available information before a decision is taken exploring the idea of an ARV-based microbicides study
While efforts have been made to provide support to research participants of both trials, there is a need to ensure protection and render benefit to communities that are constantly being chosen as preferred subjects of research, including the strengthening of community advisory boards.
The meeting emphasized the need to improve the demographics of research participants in South Africa.
The meeting also highlighted the need to build and broaden research capacity in South Africa and African continent to ensure that Africa can influence research agenda which is currently determined mainly by the sponsors.
All parties agreed that there is need for more interaction between the Department of Health and research community to promote a common perspective on issues of HIV and AIDS research.