Media statement

Medical Research Council's media statement on the microbicide clinical trial

On 31 January 2007 the USA-based agency CONRAD informed the MRC that its international clinical trial of a vaginal microbicide cellulose sulphate would have to be terminated early due to concerns by the Independent Safety Monitoring Committee that the microbicide might actually be increasing HIV transmission rather than preventing it.

All 604 women enrolled on the trial at the MRC clinical trial site have been informed, and the 20 or more who became HIV positive during the trial have been enrolled into a programme of care. It is as yet uncertain whether some of these women became HIV positive as a result of use of the microbicide, and this is currently being investigated.

All the women enrolled in the CONRAD trial were counseled at each monthly clinic visit on the issue of HIV prevention; and were given a free supply of male and or female condoms at each visit.

All MRC clinical trials are conducted according to the highest ethical standards and adhere to strict clinical trial protocols. In order however, to reassure the public on this matter the MRC has agreed, following a meeting with the Minister of Health Dr Tshabalala Msimang, that the microbicide clinical trial sites should be inspected by the National Health Research Ethics Committee.

Meanwhile the search continues for a safe and effective vaginal microbicide that would be woman-controlled, allowing some measure of protection for women from HIV infection. This is particularly important for women who, for whatever reason, have difficulty in negotiating condom use with their husband, partner or boyfriend..

Drug regulatory agencies such as the Medicine's Control Council Clinical insist new drugs or agents submitted for registration, should have been demonstrated in rigorous clinical trials to be safe, effective and of high quality. Full informed consent is obtained from the participants in the clinical trial, who are informed of the possible risks and benefits of the trial. Insurance is taken out by the sponsors of the trial in order to compensate participants should the trial go wrong. It is important that any new potential agents for HIV prevention are tested here in South Africa, if they are destined for use in South Africa; and this necessarily entails a clinical trial.  

As the statutory council for health research the Medical Research Council will endeavour to ensure that all its research is of the highest standard, and consonant with its vision of building a healthy nation through research.