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
  Purpose

To determine the prevalence and natural history of pulmonary and cardiac complications associated with HIV infection in utero, in infancy, and during early childhood.


Condition Phase
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 Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: May 1989
Estimated Study Completion Date: March 2003
Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005274

Sponsors and Collaborators
Investigators
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005274     History of Changes
Other Study ID Numbers: 1301
Study First Received: May 25, 2000
Last Updated: October 26, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Cardiovascular Diseases
Cytomegalovirus Infections
Heart Diseases
Heart Failure
Immunologic Deficiency Syndromes
Lung Diseases
Virus Diseases
Pneumonia, Pneumocystis
Pneumocystis Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Respiratory Tract Diseases
Lung Diseases, Fungal
Mycoses
Pneumonia
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 21, 2014