PEDIATRIC LATE OUTCOME PROTOCOL 219

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The major aim is to longitudinally follow infants, children, and adolescents enrolled in perinatal and pediatric ACTG clinical trials in order to monitor late consequences of therapy including long-term survival and quality of life. Among HIV-infected infants and children, the term "late outcomes" will be used generically to describe long-term consequences which may be related to HIV disease progression, treatmeent effects and/or an interaction of HIV disease and therapy. This is based on the rationale that distinguishing drug effects from disease effects may not always be possible. The term "late effects" will be used specifically to describe late consequences of antiretroviral therapies among perinatally treated infants who are ultimately proven not infected. The perinatally drug exposed but uninfected group offers the opportunity to cleanly delineate between drug and disease progression effects.