Overview

Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
Summary
In HIV hypercholesterolemic patients treated with protease inhibitors, some drugs of the statin group are used to control cholesterol level. New and potentially more efficient statins may interfere with protease inhibitors and hence loose a part of their activity. They have thus to be compared with a more established drug of the same class (e.g. pravastatin). The protocol compares the efficacy and safety of rosuvastatin and pravastatin.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Treatments:
Anti-Retroviral Agents
HIV Protease Inhibitors
Pravastatin
Protease Inhibitors
Rosuvastatin Calcium
Criteria
Inclusion Criteria:

- Fasting LDL cholesterol over 4.1 mmol/L (1.6 g/l)

- Blood triglycerides over 8.8 mmol/L (8 g/l)

- HIV-1 infection

- Viral load above or equal to 10.000 copies/ml

- Stable antiretroviral regimen for past two months

Exclusion Criteria:

- Coronary disease

- Genetic muscular disease

- CPK over 5N

- Hepatic or renal insufficiency

- Alcohol intake more than 40g/d

- Hypothyroidism

- Pregnancy and breast feeding