Impact of Antiretroviral Therapy on Cardiac Biomarkers
Recruitment status was: Recruiting
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Impact of Antiretroviral Therapy on Biomarkers of Inflammation Associated With Cardiovascular Risk|
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
10 patients starting on non-nucleoside reverse transcriptase inhibitor based regimen. 5 women and 5 men.
10 patients starting a protease inhibitor based regimen. 5 women and 5 men.
With the advent of antiretroviral therapy, death due to opportunistic diseases have seen a major decline among patients with HIV. However, several antiretroviral medications, in particular protease inhibitors (PI), have been associated with increased cardiovascular risk in large cohort studies. The role of inflammation in cardiovascular risk is currently being elucidated. High sensitivity C-reactive protein (hsCRP) has been identified as a strong independent predictor of cardiovascular disease among healthy individuals in several large cohort studies. Other inflammatory biomarkers such as serum amyloid A (SAA) and interleukin-6 (IL-6) have also been correlated with cardiovascular risk. Among patients with HIV, studies have revealed inappropriate immune activation with increased pro-inflammatory cytokines such as IL-6, IL-10, interferon-γ (IFN- γ), and tumor necrosis factor-α (TNF-α). The effects of this immune dysregulation and the impact of antiretroviral therapy on the cytokines and biomarkers associated with cardiovascular risk remain to be delineated.
Objective: Our aims are to characterize the levels of inflammatory biomarkers at the time of antiretroviral initiation, to define the time period over which the biomarkers change and stabilize, and to determine if the type of antiretroviral drug class used has an impact on the rate of alteration of these biomarkers. Given the disparate cardiovascular risk between women and men of similar age groups, we will study the additional impact of gender on these biomarkers. We will also explore whether there is a correlation between change of CD4 T-lymphocyte counts and the response of the biomarkers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641888
|United States, California|
|University of California, Davis|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Archana Maniar, MD||University of California, Davis|