Anti-AIDS drug Nevirapine remains an option for the treatment of mother to child transmission despite the deaths of five women during the course of a local trial involving the drug, according to Health minister Dr Manto Tshabalala-Msimang.
She said yesterday (Thursday) that she had “just a while ago signed letter to support the studies being done at Bara (Chris Hani Baragewanath Hospital)”.
“We have even asked them to ensure that they have more than one site so we can get really good results,” Tshabalala-Msimang said.
The Baragwanath site, where the SAINT trials were being conducted, compared Nevirapine with short course AZT and 3TC for safety and efficacy for mother to child transmission.
Nevirapine has not yet been registered in South Africa for paediatric use.
The minister reiterated that government had not stopped any other trials other than the FTC 302 trial in Port Elizabeth being conducted by Quintiles Clindepharm, that involved the five deaths.
“I was talking about one study, the FTC study,” Tshabalala-Msimang said, referring to some news reports that she had halted all Nevirapine trials.
“As a result of the deaths the Medicines Control Council (MCC) has halted any further recruitment of study subjects (in the FTC 302 trial), while full reports are being compiled on all serious adverse events, including the five deaths,” she said.
Tshabalala-Msimang said the US Food and Drug Administration had agreed with the MCC decision to halt the FTC 302 trial.
Clindepharm was conducting the trial on behalf of Triangle Pharmaceuticals, a US company.
She confirmed that two of the deaths were due to hepatitis. According to a reliable source it appeared at this stage as if a third death was also not related to the drug trial.
According to an MCC report handed to the minister 510 patients had been recruited. The trial aimed to compare FTC with Lamivudine in a triple combination regimen in people who were HIV positive and who had not yet taken any antiretroviral drugs.
The trial had two groups. One group received FTC and the other Lamivudine.
Within each group, there were three sub-groups of patients.
The patients in sub-group one and two received Nevirapine as part of their drug cocktail and sub-group three did not.
Tshabalala-Msimang said she had also asked for a comprehensive report on all HIV/AIDS related clinical trials approved by the MCC that are currently running in South Africa, or that have been completed in the past five years.
* Tshabalala-Msimang said the treatment guidelines for HIV/AIDS patients were in the process of being printed.
She said the delay had been caused around issues on the management of psychiatric patients.
“We agreed on everything in February already, we just had to clarify some issues around referral guidelines for psychiatric patients,” Tshabalala-Msimang said.