Pravastatin and Protease Inhibitors in HIV-infected Patients

Pravastatin in HIV-infected Patients Treated With Highly Active Antiretroviral Therapy

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

Inclusion Criteria:

• confirmed HIV-1 infection (ELISA confirmed by Western-Blot test) ;
• Age above 18 years
• 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,
• signed informed consent

Exclusion Criteria:

• Current AIDS event or infectious disease
• Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
• Psychiatric conditions
• Biological elevated muscular enzymes
• Chronic alcohol consumption
• Pregnancy