Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005274
First received: May 25, 2000
Last updated: October 26, 2005
Last verified: October 2005

May 25, 2000
October 26, 2005
May 1989
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Complete list of historical versions of study NCT00005274 on ClinicalTrials.gov Archive Site
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Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)
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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

Observational
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  • Acquired Immunodeficiency Syndrome
  • Lung Diseases
  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Failure
  • HIV Infections
  • Cytomegalovirus Infections
  • Pneumocystis Carinii Infections
  • Ebstein-Barr Virus Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2003
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No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00005274
1301
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Samuel Kaplan University of California
Investigator: Meyer Kattan Mount Sinai School of Medicine
Investigator: D. Kutner The Cleveland Clinic
Investigator: Stephen Lipschultz Children's Hospital Medical Center, Cincinnati
Investigator: Robert Mellins Presbyterian Hospital
Investigator: William Shearer Baylor College of Medicine
Investigator: David Teitel University of California
National Heart, Lung, and Blood Institute (NHLBI)
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP