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

This study is currently recruiting participants.

Verified by University Hospitals of Cleveland, June 2008

First Received: December 14, 2007 Last Updated: June 4, 2008 History of Changes

Sponsors and Collaborators:	University Hospitals of Cleveland Bristol-Myers Squibb
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00575939

Purpose

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 we 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.

Condition
HIV Infections Atherosclerosis

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	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

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

Changes in Carotid IMT [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Inflammatory markers [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Fasting lipids [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Insulin resistance [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Stored plasma and serum

Estimated Enrollment:	120
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2012

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575939

Contacts

Contact: Grace A McComsey, MD	2168443645	mccomsey.grace@clevelandactu.org
Contact: Norma Storer, RN	2168442752	storer.norma@clevelandactu.org

Locations

United States, Ohio
University Hospitals of Cleveland	Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Grace A McComsey, MD

Sponsors and Collaborators

University Hospitals of Cleveland

Bristol-Myers Squibb

Investigators

Principal Investigator:

Grace A McComsey, MD

Case Western Reserve University and University Hospitals of Cleveland

More Information

No publications provided

Responsible Party:	University Hospitals of Cleveland ( Grace A McComsey )
Study ID Numbers:	AIDS 070711, BMS
Study First Received:	December 14, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00575939 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

HIV
IMT
coronary
Treatment Naive

Study placed in the following topic categories:

Arterial Occlusive Diseases
Virus Diseases
Atherosclerosis
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Vascular Diseases
Disease Progression
Arteriosclerosis
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Atherosclerosis
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Vascular Diseases
Arteriosclerosis

Infection
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Cardiovascular Diseases
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009