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

Completed

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00260806

Run by

University of Miami

People needed

71

Starts

2004-08-01

Expected to finish

2006-06-01

Last updated by the study team

2014-03-18

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of Illinois - Chicago — Chicago, Illinois, United States
• Clinical Trials and Surveys Corp. (C-TASC) — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• State University of New York (SUNY) — Brooklyn, New York, United States
• Columbia University — New York, New York, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Puerto Rico — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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