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

NCT00575939 | Completed

• 2 other identifiers: AIDS 070711BMS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Atherosclerosis

Keywords

HIV; IMT; coronary; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Changes in Carotid IMT

  Annualy for 4 years

Secondary Outcomes (3)

• Increase or decrease in Inflammatory markers

  Annually for 4 years

• Changes in Fasting lipids

  Annually for 4 years

• Change in Insulin resistance by HOMA score

  Annually for 4 years

Study Arms (2)

HIV positive

HIV infected treatment naive with CD4 cell count of at least 400

Healthy controls

Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stored plasma and serum

MeSH Terms

Conditions

HIV Infections; Atherosclerosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Grace A McComsey, MD

  Case Western Reserve University and University Hospitals of Cleveland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Medicine

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: November 1, 2014
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (1)