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AzTrials

Acquired Immunodeficiency SyndromeNCT00005274

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

An observational study of Acquired Immunodeficiency Syndrome and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 100 years, men only
How many people
Not given
Where
No sites listed yet
Study dates
May 1989to Mar 2003
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

To determine the prevalence and natural history of pulmonary and cardiac complications associated with HIV infection in utero, in infancy, and during early childhood.

Read the 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

Medical subject headings
Acquired Immunodeficiency Syndrome, Lung Diseases, Cardiovascular Diseases, Heart Diseases, Heart Failure, HIV Infections, Cytomegalovirus Infections, Pneumocystis Infections

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startMay 1989
  3. Study completionMar 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005274
Sponsor's protocol ID
1301
Status last verified
Oct 2005
First submitted
25 May 2000
Last updated
14 Apr 2016
Results posted
No

Publications

  • 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.

    PubMed 7903519

  • 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.

    PubMed 9085248

  • 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.

    PubMed 8892497

  • 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.

    PubMed 9474076

  • 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.

    PubMed 9427889

  • 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.

    PubMed 10617746

  • Kovacs A, Schluchter M, Easley K, Demmler G, Shearer W, La Russa P, Pitt J, Cooper E, Goldfarb J, Hodes D, Kattan M, McIntosh K. Cytomegalovirus infection and HIV-1 disease progression in infants born to HIV-1-infected women. Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection Study Group. N Engl J Med. 1999 Jul 8;341(2):77-84. doi: 10.1056/NEJM199907083410203.

    PubMed 10395631

  • Starc TJ, Langston C, Goldfarb J, Colin AA, Cooper ER, Easley KA, Sunkle S, Schluchter MD. Unexpected non-HIV causes of death in children born to HIV-infected mothers. Pediatric Pulmonary and Cardiac Complications of Vertically Transmitted HIV Infection Study Group. Pediatrics. 1999 Jul;104(1):e6. doi: 10.1542/peds.104.1.e6.

    PubMed 10390292

  • Jenson H, McIntosh K, Pitt J, Husak S, Tan M, Bryson Y, Easley K, Shearer W. Natural history of primary Epstein-Barr virus infection in children of mothers infected with human immunodeficiency virus type 1. J Infect Dis. 1999 Jun;179(6):1395-404. doi: 10.1086/314764.

    PubMed 10228060

  • Lai WW, Lipshultz SE, Easley KA, Starc TJ, Drant SE, Bricker JT, Colan SD, Moodie DS, Sopko G, Kaplan S. Prevalence of congenital cardiovascular malformations in children of human immunodeficiency virus-infected women: the prospective P2C2 HIV Multicenter Study. P2C2 HIV Study Group, National Heart, Lung, and Blood Institute, Bethesda, Maryland. J Am Coll Cardiol. 1998 Nov 15;32(6):1749-55. doi: 10.1016/s0735-1097(98)00449-5.

    PubMed 9822105

  • Cleveland RH, Schluchter M, Wood BP, Berdon WE, Boechat MI, Easley KA, Meziane M, Mellins RB, Norton KI, Singleton E, Trautwein L. Chest radiographic data acquisition and quality assurance in multicenter studies. Pediatr Radiol. 1997 Nov;27(11):880-7. doi: 10.1007/s002470050262.

    PubMed 9361051

  • Starc TJ, Lipshultz SE, Kaplan S, Easley KA, Bricker JT, Colan SD, Lai WW, Gersony WM, Sopko G, Moodie DS, Schluchter MD. Cardiac complications in children with human immunodeficiency virus infection. Pediatric Pulmonary and Cardiac Complications of Vertically Transmitted HIV Infection (P2C2 HIV) Study Group, National Heart, Lung, and Blood Institute. Pediatrics. 1999 Aug;104(2):e14. doi: 10.1542/peds.104.2.e14.

    PubMed 10429132

  • Pitt J, Schluchter M, Jenson H, Kovacs A, LaRussa P, McIntosh K, Boyer P, Cooper E, Goldfarb J, Hammill H, Hodes D, Peavy H, Sperling R, Tuomala R, Shearer W. Maternal and perinatal factors related to maternal-infant transmission of HIV-1 in the P2C2 HIV study: the role of EBV shedding. Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV-1 Infection (P2C2 HIV) Study Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Dec 15;19(5):462-70. doi: 10.1097/00042560-199812150-00004.

    PubMed 9859959

  • Xanthos GJ, Carp D, Geromanos KL. Recognizing nurses' contributions to the clinical research process. J Assoc Nurses AIDS Care. 1998 Jan-Feb;9(1):39-48. doi: 10.1016/S1055-3290(98)80075-7.

    PubMed 9436166

  • Platzker AC, Colin AA, Chen XC, Hiatt P, Hunter J, Koumbourlis AC, Schluchter MD, Ting A, Wohl ME. Thoracoabdominal compression and respiratory system compliance in HIV-infected infants. Am J Respir Crit Care Med. 2000 May;161(5):1567-71. doi: 10.1164/ajrccm.161.5.9902066.

    PubMed 10806156

Questions about this trial

What is this clinical trial studying?

An observational study of Acquired Immunodeficiency Syndrome and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005274, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.

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