AIDS activists call for gel trials to restart

Feb 8 2007

AIDS activists in South Africa are calling for clinical trials of a microbicide gel designed to help women protect themselves against HIV to be restarted.

Trials of the gel were halted last month following preliminary reports that 604 women in KwaZulu-Natal involved in the study had contracted HIV.

The Treatment Action Campaign (TAC) group are Africa's most influential AIDS lobby group and though they support the U.S. reproductive health group CONRAD for halting the trials, TAC is concerned it will be impossible to restart the trials, even if a review of the data showed the gel was not the problem, but rather the way it was being used.

The microbicide gel 'Ushercell' is produced by Polydex Pharmaceutical in Canada, and AIDS activists had hoped it would provide a breakthrough in curbing the spread of AIDS because it was designed for women to use.

This removed the onus for protection from the virus from men who are often reluctant to us condoms.

The women in the trial were instructed to apply the gel to the vagina an hour before sexual intercourse and in the South African group 35 women among a total of some 1,600 reported contracting HIV.

As a result CONRAD halted all the trials which were underway in South Africa, India, Benin and Uganda.

The trials were in Phase III, usually the final stage before a product can be registered with a drugs regulatory authority.

TAC spokesman Mark Heywood says the researchers acted ethically and appropriately in stopping the trials but he believes they have been over cautious as no hard evidence exists that the gel is posing a significant risk.

Heywood says further analysis is needed to establish if the women affected were in fact using the gel.

Manto Tshabalala-Msimang, the South African Health Minister, has apparently ordered an inquiry, but government statements indicate that it is unclear whether those infected were the women who were given the gel or were from the control group that did not receive the microbicide.

CONRAD says every aspect of the study has been handled with the utmost care, respect and gratitude toward the female volunteers.

Tshabalala-Msimang has previously been harshly criticised because of her government's slow response to South Africa's AIDS crisis, where 5.5 million of the 45 million population carry the HIV virus.

At an international AIDS conference in Toronto last year the minister and her government were strongly condemned and ridiculed for promoting a remedy of garlic, lemon and olive oil rather than life-prolonging anti-retroviral drugs.

Since that incident she has been noticeably absent from the government's campaign against AIDS.

The National Health Research Ethics Council will apparently carry out a thorough investigation of the trials but Heywood is concerned that there will be irresponsible political exploitation of the issue.

It seems the gel had become very popular and some reports, which have alarmed health experts, suggest that women who were participants in the trial had supplied the gel to other women outside the group.