Pravastatin for Hyperlipidaemia in HIV.

Phase 4

Completed

• Conditions: HIV Infections; Lipid Metabolism; Glucose Metabolism; Metabolic Abnormality; Lipodystrophy; Cardiovascular Disease

• Registration Number: NCT00227500
• Lead Sponsor: Kirby Institute

Brief Summary

This study is a randomised, placebo-controlled study of the effect of treatment with the HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated patients with high serum cholesterol. We hypothesise that pravastatin will result in greater reductions in cholesterol than placebo when used in conjunction with appropriate dietary advice.

Detailed Description

High serum cholesterol concentrations are commonly seen in HIV-infected patients treated with some protease inhibitor medications as part of long-term antiretroviral therapy for HIV. There is concern that these elevations in cholesterol may negatively impact on long-term risk of cardiovascular disease in this patient population. Pravastatin, a HMG-CoA reductase inhibitor, is commonly used to treat hypercholesterolaemia in the general population. We aim to examine the effect of 12 weeks therapy with 40mg pravastatin daily in conjunction with dietary advice in HIV-infected patients with elevated serum cholesterol on continued protease inhibitor therapy.

After 4 weeks of dietary advice, patients will be randomised to receive either pravastatin or placebo for 12 weeks. Assessments include fasting lipid and glycaemic parameters, measures of body composition and HIV disease, and surrogate markers for cardiovascular disease.

Although previous small studies of pravastatin in this field have been performed, none has done so in a randomised placebo controlled trial taking into account all the relevant measures.

Study Timeline

• Study Start: 2001-07
• Study Completion: 2004-10
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-28
• Status Verified: 2006-06
• Last Update Submitted: 2006-06-08
• Last Update Posted: 2006-06-09

Recruitment & Eligibility

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

Inclusion Criteria

• Provide written informed consent to participate in the trial
• HIV-1 sero-positive
• Male/female >18 years age
• Currently receiving HIV protease inhibitor therapy for > 12 weeks and unlikely to require change in existing regimen during the 16 week study period
• Fasting cholesterol > 6.5 mmol/L (mean of 2 samples collected > 3 days apart)

Exclusion Criteria

• Any condition which may interfere with ability to comply with study
• Gastrointestinal disorder which may affect drug absorption
• Hypertension or congestive cardiac failure
• Lactic acidemia (serum lactate level >2.2 mmol/L)
• Any serious medical condition which may compromise the patient's safety, including pancreatitis or hepatitis within past 6 months
• Active AIDS defining conditions
• Concurrent therapy with any other lipid lowering agents, oral hypoglycaemics, anabolic steroids or insulin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Between-group difference in time weighted change from baseline in fasting serum total cholesterol

Secondary Outcome Measures

Name	Time	Method
Includes: between-group difference in time weighted change: from wk 4 in fasting serum total cholesterol as well as from baseline in HDL-cholesterol and triglycerides; in total and regional body fat; in endothelial function

Trial Locations

Locations (1)

St. Vincents Hospital; 🇦🇺 Sydney, New South Wales, Australia