Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253682
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2005-11-10
Brief Title:
Effects of Highly Active Anti-Retroviral Therapy on Cardiovascular Health in Infants of HIV-Infected Mothers
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Cardiac Status of HAART Exposed Infants of HIV-Infected Mothers CHAART I
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHAART-1
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 the association between cardiovascular measurements with HAART exposure
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL072705 | NIH | None | httpsreporternihgovquickSearchR01HL072705 |