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HIV research at Mariannhill may save babies

Liz Clarke Sunday Tribune, 5 May 2002; republished courtesy of Independent Newspapers (Pty) Ltd.
A unique immune-boosting therapy - to be tested on 60 babies in Durban - could save the lives of thousands. Sixty HIV-infected newborn babies from KwaZulu-Natal, many facing quick and certain death, will be among the world's tiniest trailblazers in the global fight to contain the pandemic.

The babies, born to HIV-positive mothers at St Mary's Hospital, Mariannhill, will become part of a world-first study to prove the effectiveness of a unique immune-boosting therapy using a dramatically reduced amount of drugs.

If successful, the economic benefits will be enormous, particularly in sub-Saharan Africa where millions die because they cannot afford even the cheapest generic anti-HIV drugs. Based on extensive and successful studies in adults, scientists believe that the lives of millions of children could be significantly enhanced, if not saved, using the same approach.

The therapy would also lessen the time a patient takes the medication, reducing the risks of long-term drug-related toxicity. The strategy, known as structured treatment interruption, (STI), involves a cocktail of approved anti-retrovirals given in an on-off cycle approach. The first treatment is administered when the infection is first detected in the infant, and thereafter in specific time segments.

The research study, due to start in June, involves babies with acute HIV infection passed to them by mothers during or shortly after birth. A single dose of Nevirapine, the subject of the recent Constitional Court appeal, is only successful in stopping the transmission of the virus from mother to child in about 50% of cases. Scientists believe that STI could provide a window of hope for these doomed children, who seldom live beyong five years and die agonising deaths.

Explaining the process, Harvard University scientist Bruce Walker said research showed that structured treatment interruption for adults newly infected with HIV can prevent the worst effects of the disease by boosting their immune reponses so that they can live for long periods without the drugs. But scientists working on the project warn that "on-off" therapy is still in the clinical study phase and cannot be used by general practitioners.

Studies suggest the interrupted treatment is most effective in cases of acute or early infection. "For this reason, HIV-infected babies could be ideal candidates," said Dr Krista Dong of Harvard, who is helping set up the research at Mariannhill.

The infants enrolled in the groundbreaking programme will be started on anti-retroviral medication directly following confirmation of HIV infection, and randomly assigned to receive either standard continuous triple therapy or triple therapy delivered in structured treatment on-off cycles.

Collaborating scientist Dr Photini Kiepiela, of the Nelson R Mandela School of Medicine, said the babies on interrupted therapy would be taken off their treatment when their viral load was undetectable (less than 400 copies per millilitre of blood). "The therapy will be resumed when their viral loads increase to 5000 copies," she said.

The babies will be given a drug cocktail containing three anti-AIDS drugs, all approved and used for children and infants in countries where these therapies are affordable. The stop-start cycle will, scientists believe, "teach" the immune system how best to control the virus by continually challenging it to recognise and destroy more and more HIV-carrying cells, promoting protective long-term immune responses once anti-retroviral medications have been discontinued.

Long-term drug-related toxicity and drug resistance are seen as an important part of the monitoring process. Scientists feel the STI route will be a feasible option while vaccine dvelopment is still in the early stages.

The South African Medicines Research Council has approved the three-year study, which is being done in collaboration with the Nelson R Mandela School of Medicine in Durban and Harvard University - Partners AIDS Research Centre - in Boston.
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