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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients presenting to an HIV clinic and an infectious diseases clinic affiliated with a tertiary care hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: California HIV/AIDS Research Program
• Investigators: Principal Investigator: Archana Maniar, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2008
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 19, 2008
• First Submitted That Met QC Criteria: March 21, 2008
• First Posted (Estimate): March 24, 2008

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Human immunodeficiency virus; Cardiovascular risk; Inflammatory biomarkers
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 200715922