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Impact of Antiretroviral Therapy on Cardiac Biomarkers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00641888
First Posted: March 24, 2008
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
University of California, Davis
March 19, 2008
March 24, 2008
July 11, 2017
March 2008
October 2014   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00641888 on ClinicalTrials.gov Archive Site
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Impact of Antiretroviral Therapy on Cardiac Biomarkers
Impact of Antiretroviral Therapy on Biomarkers of Inflammation Associated With Cardiovascular Risk
Cardiovascular risk appears to be linked to some degree with inflammation. HIV medications have been linked with cardiovascular risk. In this study we will be measuring levels of chemicals in the body associated with inflammation before and after starting HIV medications in patients with HIV. We hope to understand what happens to these chemicals once a patient with HIV is started on these medications to understand their role in cardiovascular risk.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients presenting to an HIV clinic and an infectious diseases clinic affiliated with a tertiary care hospital
HIV Infections
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  • 1
    10 patients starting on non-nucleoside reverse transcriptase inhibitor based regimen. 5 women and 5 men.
  • 2
    10 patients starting a protease inhibitor based regimen. 5 women and 5 men.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a CD4 count between 200-400 planning on initiating antiretrovirals.

Exclusion Criteria:

  • Pregnancy,
  • Recent discontinuation of an antiretroviral within the past 30 days,
  • Active intravenous drug use,
  • Acute febrile illness with temperature > 100 F,
  • Diagnosis or symptoms of acute infection within the past 30 days,
  • Opportunistic infection or surgical procedure within the past 60 days,
  • Myocardial infarction within the last 30 days,
  • Renal disease (CKD Stages 3-5), and
  • Unstable liver disease.
Sexes Eligible for Study: All
18 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00641888
200715922
No
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University of California, Davis
University of California, Davis
California HIV/AIDS Research Program
Principal Investigator: Archana Maniar, MD University of California, Davis
University of California, Davis
July 2017