Clinical trial NCT00005274: Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immunodeficiency Syndrome
Lung Diseases
Cardiovascular Diseases
Heart Diseases
Heart Failure
HIV Infections
Cytomegalovirus Infections
Pneumocystis Carinii Infections
Ebstein-Barr Virus Infections
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California
name: Samuel Kaplan
affiliation: Icahn School of Medicine at Mount Sinai
name: Meyer Kattan
affiliation: The Cleveland Clinic
name: D. Kutner
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stephen Lipschultz
affiliation: Presbyterian Hospital
name: Robert Mellins
affiliation: Baylor College of Medicine
name: William Shearer
affiliation: University of California
name: David Teitel
References:
citation: Shearer WT, Rosenblatt HM, Schluchter MD, Mofenson LM, Denny TN. Immunologic targets of HIV infection: T cells. NICHD IVIG Clinical Trial Group, and the NHLBI P2C2 Pediatric Pulmonary and Cardiac Complications of HIV Infection Study Group. Ann N Y Acad Sci. 1993 Oct 29;693:35-51. doi: 10.1111/j.1749-6632.1993.tb26255.x.
citation: Cohen HL, Davis L, Hunter J, Carp D, Geromanos K, Sunkle S. Coordinating a large multicentered HIV research project. J Assoc Nurses AIDS Care. 1997 Jan-Feb;8(1):41-50. doi: 10.1016/S1055-3290(97)80036-2.
citation: The P2C2 HIV Study Group. The pediatric pulmonary and cardiovascular complications of vertically transmitted human immunodeficiency virus (P2C2 HIV) infection study: design and methods. The P2C2 HIV Study Group. J Clin Epidemiol. 1996 Nov;49(11):1285-94. doi: 10.1016/s0895-4356(96)00230-2.
citation: Pitt J, Goldfarb J, Schluchter M, Kovacs A, Cooper E, Hodes D, McIntosh K, Peavy H, Shearer W. HIV vertical transmission rate determinations are subject to differing definitions and therefore different rates. The Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection Study Group. J Clin Epidemiol. 1998 Feb;51(2):159-64. doi: 10.1016/s0895-4356(97)00239-4.
citation: Martin R, Boyer P, Hammill H, Peavy H, Platzker A, Settlage R, Shah A, Sperling R, Tuomala R, Wu M. Incidence of premature birth and neonatal respiratory disease in infants of HIV-positive mothers. The Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted Human Immunodeficiency Virus Infection Study Group. J Pediatr. 1997 Dec;131(6):851-6. doi: 10.1016/s0022-3476(97)70032-5.
citation: Shearer WT, Lipshultz SE, Easley KA, McIntosh K, Pitt J, Quinn TC, Kattan M, Goldfarb J, Cooper E, Bryson Y, Kovacs A, Bricker JT, Peavy H, Mellins RB, Heart N, Institute LB. Alterations in cardiac and pulmonary function in pediatric rapid human immunodeficiency virus type 1 disease progressors. Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted Human Immunodeficiency Virus Study Group. Pediatrics. 2000 Jan;105(1):e9. doi: 10.1542/peds.105.1.e9.
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citation: Saidi AS, Moodie DS, Garson A Jr, Lipshultz SE, Kaplan S, Lai WW, Colan SD, Starc TJ, Shanbhag S, Easley KA, Bricker JT. Electrocardiography and 24-hour electrocardiographic ambulatory recording (Holter monitor) studies in children infected with human immunodeficiency virus type 1. The Pediatric Pulmonary and Cardiac Complications of Vertically Transmitted HIV-1 Infection Study Group. Pediatr Cardiol. 2000 May-Jun;21(3):189-96. doi: 10.1007/s002460010038.
citation: Lipshultz SE, Easley KA, Orav EJ, Kaplan S, Starc TJ, Bricker JT, Lai WW, Moodie DS, McIntosh K, Schluchter MD, Colan SD. Left ventricular structure and function in children infected with human immunodeficiency virus: the prospective P2C2 HIV Multicenter Study. Pediatric Pulmonary and Cardiac Complications of Vertically Transmitted HIV Infection (P2C2 HIV) Study Group. Circulation. 1998 Apr 7;97(13):1246-56. doi: 10.1161/01.cir.97.13.1246.
citation: Lipshultz SE, Easley KA, Orav EJ, Kaplan S, Starc TJ, Bricker JT, Lai WW, Moodie DS, Sopko G, McIntosh K, Colan SD. Absence of cardiac toxicity of zidovudine in infants. Pediatric Pulmonary and Cardiac Complications of Vertically Transmitted HIV Infection Study Group. N Engl J Med. 2000 Sep 14;343(11):759-66. doi: 10.1056/NEJM200009143431102.
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