Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)
|Acquired Immunodeficiency Syndrome Lung Diseases Cardiovascular Diseases Heart Diseases Heart Failure HIV Infections Cytomegalovirus Infections Pneumocystis Carinii Infections Ebstein-Barr Virus Infections||Phase 3|
|Study Start Date:||May 1989|
|Estimated Study Completion Date:||March 2003|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005274
|OverallOfficial:||Samuel Kaplan||University of California|
|OverallOfficial:||Meyer Kattan||Icahn School of Medicine at Mount Sinai|
|OverallOfficial:||D. Kutner||The Cleveland Clinic|
|OverallOfficial:||Stephen Lipschultz||Children's Hospital Medical Center, Cincinnati|
|OverallOfficial:||Robert Mellins||Presbyterian Hospital|
|OverallOfficial:||William Shearer||Baylor College of Medicine|
|OverallOfficial:||David Teitel||University of California|