Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005274
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2000-05-25
Brief Title:
Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection P2C2
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 to 66 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
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 25 to 66 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: