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

Completed

• Conditions: HIV Infections; Atherosclerosis

• Registration Number: NCT00575939
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-18
• Primary Completion: 2013-07
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Carotid IMT	Annualy for 4 years

Secondary Outcome Measures

Name	Time	Method
Increase or decrease in Inflammatory markers	Annually for 4 years
Change in Insulin resistance by HOMA score	Annually for 4 years
Changes in Fasting lipids	Annually for 4 years

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States