Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) University of Miami Baylor College of Medicine University of Illinois Clinical Trials and Surveys Corporation Columbia University Boston Medical Center |
---|---|
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00253682 |
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.
Condition |
---|
Cardiovascular Diseases Heart Diseases Atherosclerosis HIV Infections Cardiomyopathy, Hypertrophic |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Cardiac Status of HAART Exposed Infants of HIV-Infected Mothers (CHAART I) |
Blood samples were collected for analysis of cardiac biomarkers high sensitivity C REactive PRotein (hsCRP) and N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP).
Enrollment: | 167 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | July 2009 |
Groups/Cohorts |
---|
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.
|
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 seroreverters (HIV-uninfected infants born to HIV-infected women), representing the majority of infants in the United States exposed to HAART. Long-term consequences and toxicities associated with this exposure are not known, but severe cardiotoxicity is suggested in animal models. This study will utilize HIV seroreverter cohorts from the NIH-sponsored Women and Infants Transmission Study (WITS) and Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infections Study (P2C2) to determine how left ventricular (LV) structure and function, serum cardiac troponin T (cTnT), serum pro brain natriuretic peptide (proBNP), and serum high sensitivity C reactive protein (hsCRP) are affected by HAART exposure. In P2C2, patients were recruited from May 1990 to January 1994 from five clinical centers in the United States.
This study was initiated in 2002 in response to a 'Request for Applications' on HAART cardiovascular toxicities.
DESIGN NARRATIVE:
This study will utilize HIV seroreverter cohorts from the NIH-sponsored WITS and P2C2 cohorts to determine how LV structure and function, cTnT, proBNP, and hsCRP are affected by HAART exposure. The p2C2 seroreverter cohort has been exposed to no antiretroviral therapy or zidovudine alone (without HAART) and has persistent significantly depressed LV contractility in comparison to normal with up to 5 years of follow-up. The WITS seroreverter cohort has been exposed mostly to HAART. This cohort will determine the incremental effect of HAART on LV structure and function by following the P2C2 protocol for assessment of LV structure and function. This study will test three hypotheses: 1) that HAART exposure results in fetal and neonatal myocardiocyte injury and death (by serial assessment of cTnT [a biomarker of acute myocardial injury] in both seroreverter cohorts); 2) that HAART exposure results in impaired myocardiocyte mitochondrial function resulting in LV dysfunction (by serial assessment of proBNP [a biomarker related to LV dysfunction], LV volume and pressure increases resulting in LV stretch, and neurohormonal activation); and 3) that HAART exposure results in accelerated atherosclerosis (by serial assessment of hsCRP [a biomarker of generalized inflammation predictive of increased subsequent coronary artery disease]). This study will determine the cardiovascular effects of HAART in seroreverters and the need for future cardiovascular follow-up and cardiovascular preventive and therapeutic trials in this rapidly expanding population.
Ages Eligible for Study: | up to 2 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University of Miami School of Medicine | |
Miami, Florida, United States, 33101 | |
United States, Illinois | |
University of Illinois - Chicago | |
Chicago, Illinois, United States, 60612 | |
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10027 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Steven E. Lipshultz, MD | University of Miami |
Responsible Party: | University of Miami ( Steven E. Lipshultz, MD ) |
Study ID Numbers: | 342, R01 HL72705 |
Study First Received: | November 10, 2005 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00253682 |
Health Authority: | United States: Federal Government |
Pathological Conditions, Anatomical Arterial Occlusive Diseases Atherosclerosis Sexually Transmitted Diseases, Viral Heart Diseases Acquired Immunodeficiency Syndrome Vascular Diseases Constriction, Pathologic Aortic valve stenosis Arteriosclerosis |
Cardiomyopathies Immunologic Deficiency Syndromes Heart Valve Diseases Virus Diseases Hypertrophy HIV Infections Cardiomyopathy, Hypertrophic Sexually Transmitted Diseases Aortic Valve Stenosis Retroviridae Infections |
RNA Virus Infections Aortic Stenosis, Subvalvular Slow Virus Diseases Immune System Diseases |
Lentivirus Infections Cardiovascular Diseases Infection |