20 anti-Aids gel trial participants test positive; activists call to re-start study
Wed, 07 Feb 2007
About 20 of the 604 women who participated in the microbicide clinical trials have tested HIV positive, the SA Medical Research Council said on Wednesday.
"We are not certain yet whether these women became HIV positive as a result of the use of the microbicide, and this is being investigated," said MRC President Anthony Mbewu.
The purpose of the trials was to test the effectiveness of a vaginal microbicide - cellulose sulphate gel - in preventing the sexual transmission of HIV.
"We have asked all participants to stop using the anti-Aids gel after preliminary results of the study showed a potential to increase the risk of HIV infection instead of lowering it."
Those infected with HIV during the trial had been enrolled into a programme of care, said Mbewu.
He said the participants - all from KwaZulu-Natal - were monitored and saw medical doctors on monthly basis.
"We are still gathering all evidence to show how often they used the gel and investigate other medical factors involved."
Mbewu said the participants were not encouraged to have unprotected sex during the trial.
"At each monthly meeting they were given behavioural education and issued with male and female condoms.
"Unfortunately not all of them used protection every time they engaged in sex, like the case would be with any other women."
The researchers knew the reality that it was very difficult for women, married or single, to force their partners to use protection every time, he said.
"Some of them (participants) told researchers at the monthly meetings that they did not always use condoms during sexual intercourse.
"They said they used the gel always, but we do not know that for sure until our investigation is complete," said Mbewu.
He said consent was obtained from the participants, who were informed of the possible risks and benefits of the trial.
Insurance was taken out by the sponsors of the trial in order to compensate participants should the trial go wrong.
On Tuesday Health Minister Manto Tshabalala-Msimang requested an investigation by the research ethics council following concerns about the HIV status of the participants.
She said in a statement released: "I would request the investigation to establish whether the research followed the protocols approved by the Medicine Control Council and the ethics committees of the relevant research institutions".
She would want it to establish whether participants were given sufficient information to make informed decisions about their participation.
"While we support innovation through health research, the government of South Africa is determined to ensure that the health of our people is not compromised in the process."
The council agreed that the microbicide clinical trial sites be inspected by the Health Research Ethics committee, following the meeting with Tshabalala-Msimang.
Recently, researchers halted two studies of an anti-Aids vaginal gel in Africa and India after early results suggested it might raise the risk of HIV infection instead of lowering it.
It was "a disappointing and unexpected setback" to efforts to get a simple tool to protect women from the risk of Aids through sex, the United Nations World Health Organisation said last month.
It was reported that more than half of all new infections with the Aids virus in Africa involved women and girls.
Scientists and groups such as the Gates Foundation have long sought a method of protection women could use, even without their partners' knowledge, as many men refuse to use condoms.
AIDS activists call for gel trials to restart
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.