View Clinical Trial (Medical Research Study)
Impact of Antiretroviral Therapy on Biomarkers of Inflammation Associated With Cardiovascular Risk
| City: |
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Sacramento |
| State: |
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California |
| Zip Code: |
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95817 |
| Conditions: |
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HIV Infections |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00641888 |
| Primary Contact: |
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Principal Investigator
Archana Maniar, MD
University of California, Davis
Archana Maniar, MD
Phone: (916)734-3741
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| Backup Contact: |
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Erin Chuck, MD
Phone: (916)734-3741
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| Location Contact: |
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Sacramento, California 95817
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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