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

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ClinicalTrials.gov Identifier: NCT00005274
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : April 14, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
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 or disease
Acquired Immunodeficiency Syndrome Lung Diseases Cardiovascular Diseases Heart Diseases Heart Failure HIV Infections Cytomegalovirus Infections Pneumocystis Carinii Infections Ebstein-Barr Virus Infections

Detailed Description:


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

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Study Type : Observational
Study Start Date : May 1989
Study Completion Date : March 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005274

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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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
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: P2C2
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.


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ClinicalTrials.gov Identifier: NCT00005274    
Other Study ID Numbers: 1301
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: October 2005
Additional relevant MeSH terms:
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Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Infections
Pneumocystis Infections
Lung Diseases
Cardiovascular Diseases
Heart Diseases
Immunologic Deficiency Syndromes
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immune System Diseases
Slow Virus Diseases
Respiratory Tract Diseases
Herpesviridae Infections
DNA Virus Infections
Bacterial Infections and Mycoses