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Landmark study defines benefits of early HIV testing and treatment for infected infants
Date:11/19/2008

regardless of their state of health. An NIAID study to identify the best drug regimen for these highly vulnerable children is under way.

"The new WHO guidelines will profoundly improve the survival rate and quality of life of infants born with HIV," says Ed Handelsman, M.D., chief of the Pediatric Medicine Branch in NIAID's Division of AIDS. "We are excited that we know the best time to begin treating HIV-infected infants; the challenge now for the global community is to ensure that all HIV-infected infants who need ART receive it soon enough."

The CHER study team, lead by Avy Violari, FCPaed, and Mark F. Cotton, MMed PhD, recruited and enrolled 377 infants between 6 and 12 weeks of age who had confirmed HIV infection but normal immune system development. Originally, the infants were randomly assigned to one of three regimens: start ART immediately and continue for 40 weeks; start ART immediately and continue for 96 weeks; or defer ART until signs of clinical or immunological progression to AIDS appeared. The ART regimen consists of ritonavir-boosted lopinavir, zidovudine and lamivudine, provided by GlaxoSmithKline PLC of Britain and the South African Department of Health. CHER is being conducted at two locations in South Africa: the Perinatal HIV Research Unit of the University of Witwatersrand; and the Children's Infectious Diseases Clinical Research Unit of Tygerberg Children's Hospital and Stellenbosch University. These sites are collaborating with the Medical Research Council Clinical Trials Unit in London.

In June 2007, a data and safety monitoring board (DSMB) overseeing CHER found that the babies who received immediate ART were four times less likely to die than the babies whose treatment was deferred. This was true even though 66 percent of those in the deferred treatment arm had met the criteria for ART during the first 32 weeks of the trial and already had begun treatment. Consequently, the DSMB recommended, and NIAID agreed, t
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Contact: Laura Sivitz
sivitzl@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
Source:Eurekalert

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