NCT00253682

Brief Summary

This study will determine the impact of highly active antiretroviral therapy (HAART) on the developing cardiovascular system, the evolution of HAART-associated cardiovascular changes over time, and the association between cardiovascular measurements with HAART exposure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2002

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

4.3 years

First QC Date

November 10, 2005

Last Update Submit

March 17, 2014

Conditions

Cardiovascular DiseasesHeart DiseasesAtherosclerosisHIV InfectionsCardiomyopathy, Hypertrophic

Study Arms (2)

1

HIV-uninfected infants born to HIV-infected women with in-utero exposure to HIghly Active Ani-Retroviral Therapy (HAART) who were enrolled in the Women and Infants Transmission Study (WITS).

2

Historical cohort of HIV-uninfected infants born to HIV-infected women from the Pediatric Pulmonary and Cardiovascular Complications of HIV Study (P2C2 HIV) who were not exposed to HAART.

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

HIV-uninfected infants born to HIV-infected women with in-utero exposure to HIghly Active Ani-Retroviral Therapy (HAART) who were enrolled in the Women and Infants Transmission Study (WITS). The comparison group will be a historical cohort of HIV-uninfected infants born to HIV-infected women from the Pediatric Pulmonary and Cardiovascular Complications of HIV Study (P2C2 HIV) who were not exposed to HAART.

You may qualify if:

  • Children who are actively enrolled in the WITS study, regardless of whether or not they have been exposed to HAART therapy
  • Children enrolled into this study from one of the designated WITS clinical sites
  • Mothers or legal guardians understand and are willing to provide informed consent with or without the help of an interpreter

You may not qualify if:

  • Children diagnosed with HIV infection
  • Mother has maternal diabetes or phenylketonuria
  • Mother has been told by a physician that she has chromosomal defects
  • Mother has functional heart defects that have required medications or surgeries
  • Mother received cancer chemotherapy or radiation therapy during pregnancy
  • Mother used lithium carbonate, anticonvulsants, amphetamines, or angiotensin converting enzyme (ACE) inhibitors during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Miami School of Medicine

Miami, Florida, 33101, United States

Location

University of Illinois - Chicago

Chicago, Illinois, 60612, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (10)

  • Seeborg FO, Gay H, Schmiege LM 3rd, Bernard D, Shearer WT. Immunoglobulin G kappa [IgG kappa] and IgG lambda paraproteinemia in a child with AIDS and response to highly active antiretroviral therapy. Clin Diagn Lab Immunol. 2005 Nov;12(11):1331-3. doi: 10.1128/CDLI.12.11.1331-1333.2005.

    PMID: 16275950BACKGROUND

  • Shearer WT. Infection versus immunity: What's the balance? J Allergy Clin Immunol. 2005 Aug;116(2):263-6. doi: 10.1016/j.jaci.2005.06.001. No abstract available.

    PMID: 16083777BACKGROUND

  • Simbre VC, Duffy SA, Dadlani GH, Miller TL, Lipshultz SE. Cardiotoxicity of cancer chemotherapy: implications for children. Paediatr Drugs. 2005;7(3):187-202. doi: 10.2165/00148581-200507030-00005.

    PMID: 15977964BACKGROUND

  • Lipshultz SE, Lipsitz SR, Sallan SE, Dalton VM, Mone SM, Gelber RD, Colan SD. Chronic progressive cardiac dysfunction years after doxorubicin therapy for childhood acute lymphoblastic leukemia. J Clin Oncol. 2005 Apr 20;23(12):2629-36. doi: 10.1200/JCO.2005.12.121.

    PMID: 15837978BACKGROUND

  • Moylett EH, Hanson IC. Mechanistic actions of the risks and adverse events associated with vaccine administration. J Allergy Clin Immunol. 2004 Nov;114(5):1010-20; quiz 1021. doi: 10.1016/j.jaci.2004.09.007.

    PMID: 15536401BACKGROUND

  • Shearer WT. Importance of technology for the future of allergy and immunology. J Allergy Clin Immunol. 2004 Aug;114(2):406-8. doi: 10.1016/j.jaci.2004.06.031. No abstract available.

    PMID: 15316524BACKGROUND

  • Seeborg FO, Paul ME, Abramson SL, Kearney DL, Dorfman SR, Holland SM, Shearer WT. A 5-week-old HIV-1-exposed girl with failure to thrive and diffuse nodular pulmonary infiltrates. J Allergy Clin Immunol. 2004 Apr;113(4):627-34. doi: 10.1016/j.jaci.2004.01.763.

    PMID: 15100665BACKGROUND

  • Mone SM, Gillman MW, Miller TL, Herman EH, Lipshultz SE. Effects of environmental exposures on the cardiovascular system: prenatal period through adolescence. Pediatrics. 2004 Apr;113(4 Suppl):1058-69.

    PMID: 15060200BACKGROUND

  • Nance CL, Shearer WT. Is green tea good for HIV-1 infection? J Allergy Clin Immunol. 2003 Nov;112(5):851-3. doi: 10.1016/j.jaci.2003.08.048. No abstract available.

    PMID: 14610469BACKGROUND

  • Al-Attar I, Orav EJ, Exil V, Vlach SA, Lipshultz SE. Predictors of cardiac morbidity and related mortality in children with acquired immunodeficiency syndrome. J Am Coll Cardiol. 2003 May 7;41(9):1598-605. doi: 10.1016/s0735-1097(03)00256-0.

    PMID: 12742303BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples were collected for analysis of cardiac biomarkers high sensitivity C REactive PRotein (hsCRP) and N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP).

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesAtherosclerosisHIV InfectionsCardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesCardiomyopathiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Steven E. Lipshultz, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Voluntary Professor

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 15, 2005

Study Start

September 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

US(5)