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Impact of Antiretroviral Therapy on Cardiac Biomarkers

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ClinicalTrials.gov Identifier: NCT00641888
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief Summary:
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.

Condition or disease
HIV Infections

Detailed Description:

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.


Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Antiretroviral Therapy on Biomarkers of Inflammation Associated With Cardiovascular Risk
Actual Study Start Date : March 2008
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to an HIV clinic and an infectious diseases clinic affiliated with a tertiary care hospital
Criteria

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.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641888


Locations
United States, California
University of California, Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
California HIV/AIDS Research Program
Investigators
Principal Investigator: Archana Maniar, MD University of California, Davis
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00641888     History of Changes
Other Study ID Numbers: 200715922
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by University of California, Davis:
Cardiovascular risk
Inflammatory biomarkers
Human immunodeficiency virus

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases