Pravastatin and Protease Inhibitors in HIV-Infected Patients

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Ministry of Health, France
• Treatments: HIV Protease Inhibitors; Pravastatin; Protease Inhibitors

Criteria

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