Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)
Primary Purpose
Acquired Immunodeficiency Syndrome, Lung Diseases, Cardiovascular Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Acquired Immunodeficiency Syndrome
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005274
First Posted
May 25, 2000
Last Updated
April 13, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005274
Brief Title
Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)
Study Type
Observational
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
May 1989 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, Lung Diseases, Cardiovascular Diseases, Heart Diseases, Heart Failure, HIV Infections, Cytomegalovirus Infections, Pneumocystis Carinii Infections, Ebstein-Barr Virus Infections
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Kaplan
Organizational Affiliation
University of California
First Name & Middle Initial & Last Name & Degree
Meyer Kattan
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
First Name & Middle Initial & Last Name & Degree
D. Kutner
Organizational Affiliation
The Cleveland Clinic
First Name & Middle Initial & Last Name & Degree
Stephen Lipschultz
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
First Name & Middle Initial & Last Name & Degree
Robert Mellins
Organizational Affiliation
Presbyterian Hospital
First Name & Middle Initial & Last Name & Degree
William Shearer
Organizational Affiliation
Baylor College of Medicine
First Name & Middle Initial & Last Name & Degree
David Teitel
Organizational Affiliation
University of California
12. IPD Sharing Statement
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Results Reference
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Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/p2c2/
Available IPD/Information Identifier
P2C2
Available IPD/Information Comments
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.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/p2c2/
Available IPD/Information Type
Study Forms
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/p2c2/
Available IPD/Information Type
Manual of Procedures
Available IPD/Information URL
http://biolincc.nhlbi.nih.gov/studies/p2c2/
Learn more about this trial
Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)
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