Impact of Antiretroviral Therapy on Cardiac Biomarkers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
California HIV/AIDS Research Program
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00641888
First received: March 19, 2008
Last updated: January 19, 2010
Last verified: January 2010

March 19, 2008
January 19, 2010
March 2008
January 2010   (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.
 
Recruiting
20
December 2010
January 2010   (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.
Both
18 Years to 69 Years
No
Contact: Archana Maniar, MD (916)734-3741
Contact: Erin Chuck, MD (916)734-3741
United States
 
NCT00641888
200715922-1
No
Archana Maniar, California HIV/AIDS Research Program
University of California, Davis
California HIV/AIDS Research Program
Principal Investigator: Archana Maniar, MD University of California, Davis
University of California, Davis
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP