PEDIATRIC PULMONARY AND CARDIOVASCULAR COMPLICATIONS OF VERTICALLY TRANSMITTED HUMAN-IMMUNODEFICIENCY-VIRUS (P2C2 HIV) INFECTION STUDY - DESIGN AND METHODS

The (PC2)-C-2 HIV Study is a prospective natural history study initiat ed by the National Heart, Lung, and Blood Institute in order to descri be the types and incidence of cardiovascular and pulmonary disorders t hat occur in children with vertically transmitted HIV infection (i.e., transmitted from mother to child in utero or perinatally). This artic le describes the study design and methods. Patients were recruited fro m five clinical centers in the United States. The cohort is composed o f 205 infants and children enrolled after 28 days of age (Group I) and 612 fetuses and infants of HIV infected mothers, enrolled prenatally (73%) or postnatally at age <28 days (Group II). The maternal-to-infan t transmission rate in Group II was 17%. The HIV-negative infants in G roup II (Group IIb) serves as a control group for the HIV-infected chi ldren (Group IIa). The cohort is followed at specified intervals for c linical examination, cardiac, pulmonary, immunologic, and infectious s tudies and for intercurrent illnesses. In Group IIa, the cumulative lo ss-to-follow up rate at 3 years was 10.5%, and the 3-year cumulative m ortality rate was 24.9%. The findings will be relevant to clinical and epidemiologic aspects of HIV infection in children.