Zambian Women incensed by failed AIDS gel trial

Posted: January 6, 2010 in AIDS
Tags: , , , , , , ,

Sanday Chongo Kabange in LUSAKA, Zambia

Zambia’s Non Governmental Organisations’ Coordinating Council has joined voices calling for the arrest of researchers from the Microbicide Development Programme that administered a microbicide gel that led to 46 women to be infected with HIV at a site in southern Zambia.

MDP was behind the trials in Southern Zambia. PHOTO: dfid.org.uk

NGOCC, a consortium of civic organisations, mostly women NGOs, has condemned reports that 46 of the 1,332 women that took part in a clinical trial using a microbicide gel called PRO 2000 contracted HIV.

Group’s chairperson, Marian Munyinda, has demanded for an investigation be instituted so as to establish circumstances that led to 46 women to contract the virus.

Muyinda has demanded that researchers at the site be brought to justice as the lives of 46 infected women have been put under serious risk.

She said in Lusaka that her organisation will ensure that the rights of the 46 infected women are respected.

“ We are concerned and saddened that government has remained silent over this serious issue. We are demanding for an investigation to be instituted immediately so that we know what went wrong. The investigations should also extend to the operations of the Microbicide Development Programme because it is the organisation that spearheaded the trials. We do not want a situation where women to be used as objects in matters of life and death,” said disappointed Munyinda.

However, the Microbicide Development Programme has refuted reports that half of the 1,332 HIV-negative women who were recruited to take part in a test trial for the gel PRO 2000 were infected by the virus.

MDP Zambia principal investigator Maureen Chisembele issued a statement saying the reports were wrong and misleading.

Chisembele explained that the MDP 301 trial, which was testing whether the gel PRO 2000 would prevent HIV or not, took place in four countries, one of these centres being Mazabuka in southern Zambia.

“A lot of emphasis was put on the fact that it was not known whether PRO 2000 would work to prevent HIV, but it was known that condoms do,” she said.

She said there was a check to ensure that the women understood these two facts before they could enrol, and that repeat checks were done during follow-up.

She said condom use was promoted to all participants in the trial from the Zambian site in Mazabuka, where 1,332 women were recruited and each followed up monthly, up to one year.

“At each monthly visit, they received screening and treatment for other sexually transmitted infections; pregnancy tests and safe sex counselling including free condoms,” she said.

Chisembele said the study was completed in September 2009 and that the public release of the overall outcome of the study was done on December 14, 2009.

She said the outcome of the trial was that PRO gel 2000 was found to be safe to use but not effective against HIV, contrary to reports that half the women on the study were infected in Mazabuka.

Chisembele said the results show that only 46 out of the 1,332 women sero-converted while they were in study, meaning that there was a development of detectable antibodies in the blood directed against an infectious agent.

She said the study helped the participants as much as possible to remain negative through counselling and in condom promotions in sexually transmitted infections (STI) treatment.

Chisembele said, however, that some participants did become HIV -positive because the study was conducted in the normal environment.

She said women who became infected during the study were given further counselling and referred to local health services for anti-retroviral therapy (ART).

But Munyinda maintains that the trials that were conducted by the Microbicide Development Programme be investigated immediately.
She praised the area legislator, traditional and civic leaders for supporting the affected women and called on government to explain to the nation how the trials were sanctioned.

Meanwhile, a group of concerned Zambians planning to march to the National AIDS Council (NAC) in Lusaka where they intend to protest and petition Zambian authorities over its silent stance regarding the microbicide clinical trials in southern Zambia.

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