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Home > Studies > P2C2 > Catalog

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

Basic Study Information

Name

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

Accession Number

HLB00821111a

Acronym

P2C2

Related studies

BSI Study IDs

P2C

Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT00005274
Study type

Epidemiology Study

Collection Type

Open BioLINCC Study

Cohort type

Pediatric

Interventions

Study Open Date (Data)

2011-06-07

Study Open Date (Specimens)

2011-06-07

Date materials available

2011-06-07

Last updated

None

Study period

May 1989 - March 2003

Study Contacts
NHLBI Division

DLD

Classification

Lung

HIV study classification

HIV

COVID study classification

non-COVID

Pre-Website # of Specimens Shipped

1068

# of Returned Specimens

0

Primary Publication URLs
N/A

Study Consent

Commercial use data restrictions

No

Data restrictions based on area of research

No

Commercial use specimen restrictions

No

Non-genetic use specimen restrictions based on area of use

No

Genetic use of specimens allowed?

Yes

Genetic use area of research restrictions

No

Specific Consent Restrictions

Additional Study Information

Conditions

Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Cytomegalovirus Infections
Ebstein-Barr Virus Infections
HIV Infections
Heart Diseases
Heart Failure
Lung Diseases
Pneumocystis Carinii Infections

Objectives

The objective of this study was to determine the prevalence and natural history of pulmonary and cardiac complications associated with HIV infection in utero, in infancy, and during early childhood.

Background

In 1982, a year after the discovery of AIDS in adults, cases were described in children. Subsequent cross-sectional and short term longitudinal studies indicated that pulmonary and cardiac diseases contributed significantly to morbidity and mortality in children infected with the human immunodeficiency virus. This study aimed to investigate this hypothesis in a long-term cohort study.

Subjects

Children were enrolled at 5 geographically separated centers in Houston, TX, USA; Boston, MA; New York, NY; and Los Angeles, CA. The cohort of subjects included two groups. Group I was composed of infants and children with vertically transmitted HIV-infection over 28 days of age. Children in Group I must have been born after April 1, 1985 except where vertical transmission of HIV infection could be documented with reasonable medical certainty and be more than 28 days old. Group II was composed of fetuses and infants of mothers infected with HIV.


Subjects in group I included children who were likely to develop extensive disease during the course of the study and therefore provide the opportunity to study the full range of cardiovascular and pulmonary complications associated with vertically-transmitted HIV-infection in children. Group II provided the opportunity to determine the earliest features of infection in the fetus and longitudinally to follow these effects in the child. Since a proportion of infants in this group were not infected, they represented a control group for the infected infants.


Children in group I (n=205) were a median of 22.9 months of age at enrollment (1.7-166 months) of which 11.7% had asymptomatic infection and 88.3% presented with symptomatic infection. Among 600 infants born to HIV-1–infected women, 432 (72.0 %) were enrolled while their mothers were pregnant and 168 (28.0 %) before 28 days post partum. Among 93 HIV-1–infected infants, 29 (31.2 %) were enrolled postnatally (median, 12 days; range, 1 to 28).

Design

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. Follow-up ranged from 2.5 to 6.6 years.

Conclusions

Vertically-transmitted HIV-1 infection is associated with persistent cardiovascular abnormalities identifiable shortly after birth. Irrespective of their HIV-1 status, infants born to women infected with HIV-1 have significantly worse cardiac function than other infants, suggesting that the uterine environment has an important role in postnatal cardiovascular abnormalities.

Disease classification

Publications

[No authors listed] 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; 49(11):1285-94.


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; 131(6):851-6.


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; 105(1):e9.


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; 341(2):77-84.


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; 104(2):e14.


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; 343(11):759-66.

Mat types

Serum

Study Population

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    Group 1: 205

    Group 2: 611


    Last Modified: July 28, 2014, 1:49 p.m.
  • Age
  • Sex

     

    Group 1

    Group 2

    All

    N

    %

    N

    %

    N

    %

    Missing

    0

    0

    11

    1.80

    11

    1.35

    Male

    94

    45.85

    316

    51.72

    410

    50.25

    Female

    111

    54.15

    284

    46.48

    395

    48.41

     

    Last Modified: March 8, 2016, 12:16 p.m.
  • Race
     

     

    Group 1

    Group 2

    All

    N

    %

    N

    %

    N

    %

    Unknown

    0

    0

    11

    1.80

    11

    1.35

    Black

    89

    43.41

    309

    50.57

    398

    48.77

    Hispanic

    82

    40.00

    182

    29.79

    264

    32.35

    Other

    34

    16.59

    109

    17.84

    143

    17.52

     
    Mother's Race:

     

    Group 1

    Group 2

    All

    N

    %

    N

    %

    N

    %

    Unknown

    3

    1.46

    32

    5.24

    35

    4.29

    Black

    86

    41.95

    291

    47.63

    377

    46.20

    Hispanic

    80

    39.02

    184

    30.11

    264

    32.35

    Other

    36

    17.56

    104

    17.02

    140

    17.16

     

    Last Modified: March 8, 2016, 12:16 p.m.

Available Biospecimens

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process

  • Material Types
  • General Freeze/Thaw Status
  • Visits (Vials)

    10/26/2018

      Serum Total
    Subjects with 1 visit 562 562
    Subjects with 2 visits 509 509
    Subjects with 3-10 visits 5,011 5,011
    Subjects with 11+ visits 1,033 1,033
    Subjects with no visit date 207 207

     

    Last Modified: Oct. 26, 2018, 12:16 p.m.
  • Visits (Subjects)

    9/29/2015

      Serum
    Total number of subjects Average volume (ml) per subject
    Subjects with 1 visit 399 0.89
    Subjects with 2 visits 138 1.61
    Subjects with 3-10 visits 396 4.43
    Subjects with 11+ visits 41 10.80
    Subjects with no visit date 175 0.53

     

    Last Modified: Oct. 26, 2018, 12:16 p.m.
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