HIV Infections Clinical Trial
To determine the prevalence and natural history of pulmonary and cardiac complications associated with HIV infection in utero, in infancy, and during early childhood.
BACKGROUND:
In 1982, a year after the discovery of AIDS in adults, cases were described in children.
Subsequent reports clearly indicated that pulmonary and cardiac diseases contributed
significantly to morbidity and mortality in children infected with the human
immunodeficiency virus.
The initiative was developed by the staff of the Division of Lung Diseases and the Division
of Heart and Vascular Diseases after consultation with members of the pulmonary, cardiology,
and pediatric communities. The Request for Proposals was released in August 1988 and awards
made in May 1989.
DESIGN NARRATIVE:
In this prospective natural history study, research was conducted on the response of the
immature lung to Pneumocystis carinii and other opportunistic lung infections, as well as on
the etiology and pathogenesis of lymphocytic pulmonary disorders. The types, incidence,
course, outcome, and origin of cardiac disorders were also determined. In addition to the
pulmonary and cardiovascular measurements, data on the effects of co-infection with other
viruses, CMV and EBV, were obtained.
Enrollment of participants began in May 1990 and continued through April 1993 in Group I and
through January 1994 for Group II. The cohort was followed at specified intervals for an
additional three years beyond the end of recruitment for clinical examination, cardiac,
pulmonary, immunologic, and infectious studies and for intercurrent illnesses (The cohorts
were followed through January 1997). Follow-up ranged from 2.5 to 6.6 years. The study ends
in July 2002. Analysis of the database, preparation of manuscripts and follow-up of adult
type pulmonary function studies in infants currently followed at sites conducting the Womens
& Infants Transmission Study (WITS) continue through July 2002
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N/A
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Phase 2 |