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Impact of Antiretroviral Therapy on Cardiac Biomarkers

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.
 
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

Tracking Information
First Submitted Date March 19, 2008
First Posted Date March 24, 2008
Last Update Posted Date July 11, 2017
Actual Study Start Date March 2008
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Antiretroviral Therapy on Cardiac Biomarkers
Official Title Impact of Antiretroviral Therapy on Biomarkers of Inflammation Associated With Cardiovascular Risk
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients presenting to an HIV clinic and an infectious diseases clinic affiliated with a tertiary care hospital
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 6, 2017)
40
Original Estimated Enrollment
 (submitted: March 21, 2008)
20
Actual Study Completion Date October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00641888
Other Study ID Numbers 200715922
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, Davis
Study Sponsor University of California, Davis
Collaborators California HIV/AIDS Research Program
Investigators
Principal Investigator: Archana Maniar, MD University of California, Davis
PRS Account University of California, Davis
Verification Date July 2017