Clinical trial NCT00641888: Impact of Antiretroviral Therapy on Cardiac Biomarkers
Official title: Impact of Antiretroviral Therapy on Biomarkers of Inflammation Associated With Cardiovascular Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Cardiovascular risk
Inflammatory biomarkers
Human immunodeficiency virus
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: California HIV/AIDS Research Program
First posted: 2008-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to an HIV clinic and an infectious diseases clinic affiliated with a tertiary care hospital

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: University of California, Davis
name: Archana Maniar, MD
role: PRINCIPAL_INVESTIGATOR
References: