Long-term Effects of Highly Active Anti-Retroviral Therapy on HIV-Infected Children

NCT00260806 | Completed DMC

• 2 other identifiers: 1318R01HL078522
• Study Type: observational
• Target: 71
• Locations: 2 countries
• Sites: 9

Brief Summary

This study will use the NIH-sponsored Women and Infants Transmission Study (WITS) and the Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2) HIV-infected pediatric cohorts to determine how left ventricular (LV) function (particularly fractional shortening and contractility) and structure (particularly wall thickness and mass) are affected by cumulative intensity of exposure to highly active anti-retroviral therapy (HAART).

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Cardiac systolic function

  Measured from 2 years of age to 18 years of age

Study Arms (2)

1

Children perinatally infected with HIV with exposure to highly active anti-retroviral therapy (HAART).

2

Children with perinatally acquired HIV infection enrolled on the P2C2 Study, not exposed to HAART therapy.

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be children perinatally infected with HIV who were enrolled in the Women and Infants Transmision Study (WITS). This cohort will be compared to the historical Pediatric Pulmonary and Cardiovacular Complications Study (P2C2 HIV) cohort of perinatally HIV-infected children not exposed to HAART.

You may qualify if:

• HIV-infected children
• Mothers of children understand and are willing to provide informed consent
• Mothers of children are capable of answering in English or with the help of an interpreter

You may not qualify if:

• HIV-infected child who is too young (less than 2 years of age) or otherwise unable to undergo an echocardiogram without sedation
• Mothers of children have maternal diabetes or phenylketonuria
• Mothers of children have a recognized Mendelian or chromosomal defect
• Mothers of children are/were actively receiving chemotherapy for cancer during pregnancy
• Mothers of children used lithium carbonate, anticonvulsants, amphetamines, or angiotensin converting enzyme (ACE) inhibitors on a chronic basis

Sponsors & Collaborators

• University of Miami: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Clinical Trials & Surveys Corp (C-TASC): collaborator
• Baylor College of Medicine: collaborator
• University of Illinois at Chicago: collaborator
• Columbia University: collaborator
• Boston Medical Center: collaborator
• Boston Children's Hospital: collaborator
• University of Puerto Rico: collaborator
• State University of New York: collaborator

Study Sites (9)

University of Miami Miller School of Medicine

Miami, Florida, 33101, United States

Location

University of Illinois - Chicago

Chicago, Illinois, 60612, United States

Location

Clinical Trials and Surveys Corp. (C-TASC)

Baltimore, Maryland, 21210, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

State University of New York (SUNY)

Brooklyn, New York, 11203, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Puerto Rico

San Juan, Puerto Rico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells (PBMCs) were collected from the WITS cohort to investigate the presence of mitochondrial DNA (mtDNA) mutations.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System 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: December 1, 2005
• First Posted: December 2, 2005
• Study Start: August 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

US (8); PR (1)