HIV Infections Clinical Trial
Official title:
A Randomised, Double-Blind Study of Pravastatin for the Treatment of Hyperlipidaemia in Patients With HIV
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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