Impact of Antiretroviral Therapy on Cardiac Biomarkers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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 (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

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


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

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

ClinicalTrials.gov processed this record on June 23, 2017

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