About 20 of the 604 women who participated in microbicide clinical trials have tested HIV-positive, the South African Medical Research Council (MRC) 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.
Microbicides are compounds, such as gels or creams, applied to the vagina or rectum, which researchers hope will prevent the sexual transmission of HIV and other infections.
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,” said Mbewu.
Those infected with HIV during the trial have been enrolled in a care programme, he said.
Monitored
Mbewu said the trial 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 that it was very difficult in reality 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, and they 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 it go wrong.
Investigation
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: ”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 such an investigation 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 has been reported that more than half of all new infections with Aids in Africa involve women and girls.
Scientists and groups such as the Gates Foundation have long sought a method of protection available to women, even without their partners’ knowledge, as many men refuse to use condoms.
Myth
It is a myth that participants in microbicide trials are encouraged to have unprotected sex, the Treatment Action Campaign (TAC) said on Wednesday.
”This myth has been perpetuated by at least two senior South African politicians and we have encountered journalists who have mistakenly believed it,” the organisation said in an online newsletter.
In the myth’s most extreme version, it is said people undergoing microbicide trials, as well as those on vaccine trials and the recently conducted circumcision trials, are exposed to HIV by researchers. ”This is false. On the contrary, participants in these trials must be counselled about safer sex,” the TAC said.
”If a trial is conducted properly, participants are arguably at less risk of contracting HIV than the general population, because they have all been through a standardised comprehensive counselling session, approved by a regulatory ethics committee.” — Sapa