Pravastatin and Protease Inhibitors in HIV-Infected Patients
To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy|
- HIV RNA [ Time Frame: at 12 weeks ]
- Lipid biological markers
- Plasma level of protease inhibitors
- CD4 count at 12 weeks
|Study Start Date:||March 2003|
|Study Completion Date:||March 2004|
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
|Hôpital Saint André, Service de médecine interne et maladies infectieuses|
|Bordeaux, France, 33000|
|Principal Investigator:||Fabrice BONNET, Dr||University Hospital Bordeaux, France|
|Study Chair:||Geneviève CHENE, Pr||University Hospital, Bordeaux France|