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Multicenter Study
. 1996 Nov;49(11):1285-94.
doi: 10.1016/s0895-4356(96)00230-2.

The pediatric pulmonary and cardiovascular complications of vertically transmitted human immunodeficiency virus (P2C2 HIV) infection study: design and methods. The P2C2 HIV Study Group

The P
Multicenter Study

The pediatric pulmonary and cardiovascular complications of vertically transmitted human immunodeficiency virus (P2C2 HIV) infection study: design and methods. The P2C2 HIV Study Group

The P. J Clin Epidemiol. 1996 Nov.

Abstract

The P2C2 HIV Study is a prospective natural history study initiated by the National Heart, Lung, and Blood Institute in order to describe the types and incidence of cardiovascular and pulmonary disorders that occur in children with vertically transmitted HIV infection (i.e., transmitted from mother to child in utero or perinatally). This article describes the study design and methods. Patients were recruited from five clinical centers in the United States. The cohort is composed of 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-infant transmission rate in Group II was 17%. The HIV-negative infants in Group II (Group IIb) serves as a control group for the HIV-infected children (Group IIa). The cohort is followed at specified intervals for clinical examination, cardiac, pulmonary, immunologic, and infectious studies and for intercurrent illnesses. In Group IIa, the cumulative loss-to-follow-up rate at 3 years was 10.5%, and the 3-year cumulative mortality rate was 24.9%. The findings will be relevant to clinical and epidemiologic aspects of HIV infection in children.

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Figures

FIGURE 1
FIGURE 1
Cumulative rates of loss to follow-up, estimated by the Kaplan-Meier method, are plotted for Groups I, IIa, and IIb using information available through of March 31, 1996. The cumulative loss-to-follow-up rate for all Group II children (not shown) is higher than for Groups IIa or IIb because the rates for Groups IIa and IIb exclude HIV-indeterminate children who are lost to follow-up before their HIV status can be determined. Loss-to-follow-up rates for all Group II children combined, including HIV indeterminates, are 26.9%, and 38.3% at 24 and 36 months, respectively.
FIGURE 2
FIGURE 2
The cumulative mortality curve for the Group IIa children, estimated by the Kaplan-Meier method, is shown with 95% confidence limits (dotted lines).
See this image and copyright information in PMC

References

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