Sunday Times (Johannesburg) - February 5, 2006
Claire Keeton

The ambitious trial is one of the first in the world to treat people with antiretroviral drugs during the early months of infection, as opposed to later.

The researchers hope to block the virus before it severely damages the immune system - and thus delay the onset of lifelong therapy.

Director of the HIV Prevention Unit at the South African Medical Research Council in Durban, Professor Gita Ramjee, said: "Globally, the treatment of infection may be coming too late, when the immune system is compromised and people are very sick."

Trial steering committee chairman Sir Alasdair Breckenridge emphasised that this was not a trial to test drugs, but to test a new strategy.

"It is a pioneering trial and, if successful, it will have huge implications for the way we treat HIV," he said.

The Durban trial site, one of several worldwide recruiting for the "Spartac" study, has enrolled 11 volunteers since November and hopes to enlist 100. The trial aims to enrol 360 volunteers worldwide through centres including the MRC site, the Desmond Tutu HIV/Aids Research Centre at the University of Cape Town and the Reproductive Health and HIV Research Unit at Wits University.

Recruitment is difficult because the researchers need to sign up people with HIV at a stage when most of them do not yet know that they have been infected, as there are often no clear symptoms in the early stages of infection.

Ramjee said they were recruiting people from HIV-prevention trials who had become HIV-positive.

Volunteers on these prevention trials - for example, for microbicides or vaccines against HIV - are tested every three months for the virus.

Ramjee said: "There has been a lot of education and most people [approached] have consented to join."

She said: "The side effects are not as pronounced because people are healthy, and the adherence is good."

Volunteers will be divided into three groups: one group will get antiretroviral drugs for three months, the second group will get the drugs for one year, and the third group will get a placebo or no drug.

For ethical reasons, this may be one of the last HIV trials internationally to include a placebo said Breckenridge.

He said it was nonetheless ethical since nobody was treating primary infection at the moment.

Breckenridge, chairman of the UK Medicines and Healthcare Products Regulatory Agency, said the steering committee had sought to conduct the trial in Russia as well, but the chief virologist with whom they were dealing had died and the committee pulled out.

Spartac national investigator Dr Francois Venter said that this would be the first large, well-controlled trial to test treatment in the first six months of infection.

"The others were small and not very well controlled, and their results have been disappointing.

He said: "This study will give us good information and evidence on how immune responses work."

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