To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.
Background. Highly Active AntiRetroviral Therapy including protease inhibitors is associated with elevated plasma lipid levels. Design. randomized double-blind, multicentric. Intervention. Pravastatin versus placebo for 12 weeks. Eligibility criteria. Positive for anti-VIH antibodies, stable antiretroviral therapy including at least one PI for \>= 3 months, plasma HIV-RNA level of \< 50 copies/mL for \>= 3 months before randomization, total cholesterol \>= 5.5 mmol/L with LDL-cholesterol \>= 3.4 mmol/L on fasting status after three months of standardized dietary advice, written informed consent Outcomes. HIV RNA at 12 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
Hôpital Saint André, Service de médecine interne et maladies infectieuses
Bordeaux, France
HIV RNA
Time frame: at 12 weeks
Lipid biological markers
Plasma level of protease inhibitors
CD4 count at 12 weeks
Safety
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