Pravastatin for Hyperlipidaemia in HIV.

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV

Conditions
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HIV Infections, Lipid Metabolism, Glucose Metabolism, Metabolic Abnormality, Lipodystrophy, Cardiovascular Disease

Intervention / Treatment
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* Drug: Pravastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pravastatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-group difference in time weighted change from baseline in fasting serum total cholesterol |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Hyperlipidaemia, Lipid metabolism, Glucose metabolism, HMG CoA reductase inhibitors, Lipodystrophy, Cardiovascular disease, Treatment Experienced