Antiretrovirals and Rate of Progression in Carotid Artery Intima-medial Thickness in HIV

December 18, 2014 updated by: Grace McComsey, University Hospitals Cleveland Medical Center

Assessment of the Use of a Metabolically-friendly Antiretroviral Regimen to Slow Down the Rate of Progression in Carotid Artery Intima-medial Thickness in Adults With HIV

It is well known that HIV-infected subjects frequently experience hyperlipidemias, insulin resistance, and visceral adiposity, which are known to increase the risk of atherosclerosis. Several cohorts have shown an increased risk of heart disease in people with HIV. The effect of HIV treatment versus HIV itself on the incidence of heart disease is unclear. In this study the investigators will assess the effect on carotid IMT of the initiation of antiretroviral combinations that are known to have a minimal effect on lipids and insulin resistance. We will also assess the changes in several inflammation and cardiovascular markers,as well as endothelial activation markers,and how these changes relate to therapy-induced changes in immunologic, virologic and metabolic markers.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

80 HIV-infected adults older than 18 years of age, ART-naïve with CD4 count of at least 400 cells/mm3

The control group will be adults, healthy controls with no active infection or inflammatory condition, who are matched by gender and age to the HIV positive group

Description

Inclusion Criteria for HIV positive group:

  • HIV-1 infection
  • Age at least 18 years
  • Naïve to antiretroviral therapy
  • CD4 cell count > 400 cells/mm3

For controls: Age at least 18 years, no known HIV infection, and no known medical condition requiring chronic use of prescription medications.

Exclusion Criteria (both groups):

  • Diabetes
  • Pregnant or breastfeeding
  • Women of child bearing age who refuse or are unable to use appropriate methods of contraception during the entire study period.
  • Active infectious or inflammatory condition
  • In jail or involuntarily incarcerated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
HIV positive
HIV infected treatment naive with CD4 cell count of at least 400
Healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Carotid IMT
Time Frame: Annualy for 4 years
Annualy for 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase or decrease in Inflammatory markers
Time Frame: Annually for 4 years
Annually for 4 years
Changes in Fasting lipids
Time Frame: Annually for 4 years
Annually for 4 years
Change in Insulin resistance by HOMA score
Time Frame: Annually for 4 years
Annually for 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Grace A McComsey, MD, Case Western Reserve University and University Hospitals of Cleveland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIDS 070711
  • BMS (Other Identifier: BMS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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