Statin Therapy to Improve Atherosclerosis in HIV Patients

Not Applicable

Completed

• Conditions: Cardiovascular Disease; HIV; Atherosclerosis; Inflammation; Statins, HMG-CoA; HIV Infections
• Interventions: Drug: Placebo; Drug: atorvastatin

• Registration Number: NCT00965185
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

In HIV patients, statin therapy will attenuate plaque inflammation, thus, making plaques less vulnerable, will deter plaque progression, and improve endothelial function. In addition to known cholesterol-lowering and C-reactive protein lowering effects, immunomodulatory effects of statins will lead to a shift from pro-inflammatory monocyte and T cell subsets to less atherogenic subpopulations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Study Start: 2009-09
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2015-01-30
• Results First Submitted QC: 2015-02-17
• Results First Posted: 2015-02-26
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-09
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
Atorvastatin	atorvastatin	20 mg PO QD for the first 3 months, followed by 40 mg PO QD for the final 9 months.

Primary Outcome Measures

Name	Time	Method
Coronary and Aortic Plaque Inflammation	Measured at baseline and 1 year	12 month change in mean FDG-PET TBR (18-fluorodeoxyglucose positron emission tomography target-to-background ratio)

Secondary Outcome Measures

Name	Time	Method
Liver Function Tests (LFTs)	Measured at baseline, 1, 3, 6, 9, and 12 months	Number of participants with LFT abnormalities (greater than or equal to 3 times the upper limit of normal).; For reference, the normal ranges for AST and ALT are shown below. Please note that the normal range for ALT at Labcorp changed over the course of the study. AST and ALT elevations were determined based on the normal range at the time the lab test was performed.; ALT: 0-40 IU/L, 0-44 IU/L, or 0-55 IU/L AST: 0-40 IU/L
Plaque Progression	Measured at baseline and 1 year	12 month percent change in plaque volume
Endothelial Function	1 year	Assessment of endothelial function was to be measured by endothelial vasodilator function.
Immune Function	Measured at baseline and 1 year	12 month change in CD4 T-lymphocytes
Lipid Profile	Measured at baseline and 1 year	12 month change in lipid profile
C-reactive Protein (CRP)	Measured at baseline and 1 year	12 month change in Log CRP concentration
Adipocytokines	Measured at baseline and 1 year	12 month change in IL-6

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States