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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575939
• Other study ID #: AIDS 070711
• Secondary ID: BMS
• Status: Completed
• Phase: N/A
• First received: December 14, 2007
• Last updated: December 18, 2014
• Start date: November 2007
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• HIV Infections

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Carotid IMT		Annualy for 4 years	Yes
Secondary	Increase or decrease in Inflammatory markers		Annually for 4 years	No
Secondary	Changes in Fasting lipids		Annually for 4 years	Yes
Secondary	Change in Insulin resistance by HOMA score		Annually for 4 years	Yes