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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00575939

Enrollment

120

Registered

2007-12-18

Start date

2007-11-30

Completion date

2014-11-30

Last updated

2014-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, HIV Infections

Keywords

HIV, IMT, coronary, Treatment Naive

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Changes in Carotid IMT	Annualy for 4 years

Secondary

Measure	Time frame
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

Countries

United States

Outcome results