Status:
COMPLETED
Effects of Highly Active Anti-Retroviral Therapy on Cardiovascular Health in Infants of HIV-Infected Mothers
Lead Sponsor:
University of Miami
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Baylor College of Medicine
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
Up to 2 years
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 th...
Detailed Description
BACKGROUND: HIV-infected pregnant women frequently receive HAART, which is associated with reduced maternal-fetal transmission of HIV infection. This has resulted in a rapidly increasing number of se...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00253682
Start Date
September 1 2002
End Date
December 1 2006
Last Update
March 18 2014
Active Locations (5)
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1
University of Miami School of Medicine
Miami, Florida, United States, 33101
2
University of Illinois - Chicago
Chicago, Illinois, United States, 60612
3
Boston Medical Center
Boston, Massachusetts, United States, 02118
4
Columbia University
New York, New York, United States, 10027