ACTG 356 EARLY INTENSIVE ANITRETROVIRAL COMBINATION THERAPY IN HIV 1 CHILDREN

$0M01FY2002RRNIH

Johns Hopkins University, Baltimore MD

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Abstract

This protocol hypothesizes that use of combination antiretroviral therapy will allow long-term control of viral replication with preservation of normal immune function when administered early in life to HIV-1 infected children. Specifically, this study will examine the antiretroviral activity of ZDV/3TC/NVP/NFV in vertically-infected infants and children aged >15 days to 29 days, and d4T/3TC/NVP/ NFV in vertically-infected infants and children aged >30 days. Laboratory assays will be conducted in order to assess HIV-1 and CD4/CD8 T cell kinetics, activation, and maturation. The study will also test the concept that early (< 3 months of age) use of potent, combination antiretroviral therapy will allow the long term control of viral replication with preservation of normal immune function.

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