ACTG #219C: PEDIATRIC LATE OUTCOMES PROTOCOL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an observational trial to investigate the late outcomes of children infected with HIV or children exposed to HIV antiretroviral treatment in utero and in early infancy. Among HIV-infected infants and children, the term "late outcomes" will be used generically to describe long-term consequences that may be related to HIV disease progression, treatment effects (including prophylaxis and treatment of opportunistic diseases), and/or interactions of HIV disease and therapy. This is based on the rationale that distinguishing drug effects from disease effects may not always be possible. The major aim of the protocol was to longitudinally follow infants, children, and adolescents who had participated in PACTG clinical trials in order to monitor late consequences of therapy including effects on long-term survival and quality of life. The trial collects natural history data for diagnoses, signs and symptoms, medications, procedures, growth and development, nutrition, psycho-social parameters, neurodevelopmental evaluations, immunologic and virologic status, and disease progression. The first version of this long-term follow-up protocol (Version 1.0) was implemented in 1993. It has been revised on three occasion (currently Version 4.0) to improve long-term follow-up of infants now surviving to older ages, as well as to recognize the positive impact of perinatal intervention trials. The current version includes hypotheses under Perinatal, Primary Therapy, Complications and Supportive Care/Quality of Life issues. The demographics of all versions of PACTG 219/219C patients reflect the population of pediatric HIV infected patients followed at PACTG sites across the USA. The anticipated number of children enrolled (4150) allows the primary and secondary objectives, as well as the 13 hypotheses of PACTG 219C to be addressed with high power.