Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)
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Accession Number
HLB00821111a
Study Type
Epidemiology Study
Collection Type
Open BioLINCC Study
See bottom of this webpage for request information
Study Period
May 1989 - March 2003
NHLBI Division
DLD
Dataset(s) Last Updated
January 3, 2018
Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT00005274
Primary Publication URLs
N/A
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
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.
Participants
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.
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.
Additional Details
Group 1: 205
Group 2: 611
| Subjects (N) | Median Age (days) | Median Age (months) |
---|---|---|---|
Group I (Asymptomatic) | 22 | 684 | 22.5 |
Group I (Symptomatic) | 183 | 695 | 22.8 |
Group II A (Postnatal) | 29 | 12 | 0.4 |
Group II A (Prenatal) | 67 | -58 | -1.9 |
Group II B (Postnatal) | 125 | 11 | 0.4 |
Group II B (Prenatal) | 339 | -82 | -2.7 |
Group II i (Postnatal) | 14 | 7 | 0.2 |
Group II i (Prenatal) | 37 | -51 | -1.7 |
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 |
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 |
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
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 |
2/2/2024
Subjects with at least 1 specimen:
| Subjects with Specimens (N) |
---|---|
Group I (Asymptomatic) | 21 |
Group I (Symptomatic) | 157 |
Group II A (Postnatal) | 27 |
Group II A (Prenatal) | 60 |
Group II B (Postnatal) | 113 |
Group II B (Prenatal) | 298 |
Group II i (Postnatal) | 3 |
Group II i (Prenatal) | 8 |
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 |
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Resources Available
Specimens and Study DatasetsMaterials Available
- Serum
- For a number of vials the freeze thaw status is not known.
- More Details
Study Documents
- Data Dictionary (PDF - 1.9 MB)
- As Needed Forms (PDF - 1.2 MB)
- Cardiac Forms (PDF - 1.2 MB)
- General Routine Forms (PDF - 1.4 MB)
- Immunology and Virology Forms (PDF - 790.1 KB)
- Manual of Operations (PDF - 9.1 MB)
- Protocol (PDF - 9.2 MB)
- Publications (PDF - 41.6 KB)
- Pulmonary Forms (PDF - 1.9 MB)
- Routine Forms Specifically for Mother (PDF - 616.3 KB)
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