Status:
COMPLETED
Long-term Effects of Highly Active Anti-Retroviral Therapy on HIV-Infected Children
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Clinical Trials & Surveys Corp (C-TASC)
Conditions:
HIV Infections
Eligibility:
All Genders
2-18 years
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-infect...
Detailed Description
BACKGROUND: HIV-infected children are often given HAART to reduce HIV-associated disease. The long-term effects and toxicities associated with this chronic therapy in children are unknown, but severe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00260806
Start Date
August 1 2004
End Date
June 1 2006
Last Update
March 18 2014
Active Locations (9)
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1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33101
2
University of Illinois - Chicago
Chicago, Illinois, United States, 60612
3
Clinical Trials and Surveys Corp. (C-TASC)
Baltimore, Maryland, United States, 21210
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115