s.africa orders probe into botched hiv gel trials

 Source: Reuters 
 
February 7, 2007: South Africa said on Tuesday it had ordered an inquiry following reports that participants in the clinical trial of a microbicide gel to help prevent HIV infection among women had instead contracted the virus.

The U.S. reproductive health group CONRAD said last month it was halting trials of Canada-based Polydex Pharmaceutical's ushercell gel which were underway in South Africa, India, Benin and Uganda.

Johannesburg's City Press reported on Sunday that some of the 600 women in the South Africa trial had reported contracting HIV after using the gel, which is applied to the vagina an hour before sexual intercourse.

"I have asked the National Health Research Ethics Council to conduct a thorough investigation into this matter," Health Minister Manto Tshabalala-Msimang said in a statement.

The minister said the investigations began last month and that she had held a meeting on Tuesday with researchers involved in at least five of the trials.

The South Africa trials have centred mainly on KwaZulu-Natal, its most populous province and epicentre of an HIV scourge affecting some 5.5 million of the country's 45 million people.

The minister said the investigation would seek to establish whether the trials followed all ethical protocols and whether the women were given sufficient information to make informed decisions on their participation.

It would also look into other microbicide trials in the country to ensure they were following necessary guidelines.

The statement did not say how many of the women were known to have contracted HIV, but health ministry spokesman Sibani Mngadi said he had heard a figure of 22.

He said it was not clear whether those infected were from the group given the gel or from a control group that did not receive the microbicide.

"The KZN (KwaZulu-Natal) trial has been stopped and we hope the gel has been retrieved from the community, and those who are infected are receiving support," Mngadi said.

City Press said health ministry officials had fanned out across KwaZulu-Natal trying to track down the participants, many of whom had disappeared.

It said the gel had become so popular some participants had sold their supplies to other women not involved in the trial.

South Africa is grappling with one of the world's highest HIV infection rates and experts at an AIDS conference in Cape Town last year hailed microbicides as the possible breakthrough to curbing the epidemic.

When CONRAD halted the trials last month, Plydex president and CEO Goerge Usher was quoted as saying the ushercell gel had shown a consistent safety profile to that point having undergone 11 clinical safety and contraceptive trials involving more than 500 participants before entering the HIV prevention trial.