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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Acquired Immunodeficiency Syndrome

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    April 13, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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

    Citations:
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    7903519
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    9859959
    Citation
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    10806156
    Citation
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    11158466
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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/

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

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