Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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
History of Changes
  Purpose

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
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Antiretroviral Therapy on Biomarkers of Inflammation Associated With Cardiovascular Risk

Resource links provided by NLM:

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

Further study details as provided by University of California, Davis:
Estimated Enrollment: 20
Study Start Date: March 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility
Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641888

Contacts
Contact: Archana Maniar, MD (916)734-3741
Contact: Erin Chuck, MD (916)734-3741

Locations
United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Principal Investigator: Archana Maniar, MD         
Sub-Investigator: Erin Chuck, MD         
Sponsors and Collaborators
University of California, Davis
California HIV/AIDS Research Program
Investigators
Principal Investigator: Archana Maniar, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Archana Maniar, California HIV/AIDS Research Program
ClinicalTrials.gov Identifier: NCT00641888     History of Changes
Other Study ID Numbers: 200715922-1
Study First Received: March 19, 2008
Last Updated: January 19, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on March 02, 2015