Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI)
Information source: French National Agency for Research on AIDS and Viral Hepatitis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemia; HIV Infections
Intervention: Pravastatin (Drug); Rosuvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: French National Agency for Research on AIDS and Viral Hepatitis Official(s) and/or principal investigator(s):
Elisabeth Aslangul, MD, Principal Investigator, Affiliation: Hopital Hôtel Dieu Paris
Dominique Costagliola, Study Director, Affiliation: Inserm U720 Paris Pitié Salpétrière
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.
Clinical Details
Official title: Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Compare the change in LDL cholesterol between D0 and D45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted protease inhibitor on D45.
Secondary outcome: Changes in triglycerides and HDL cholesterol on D45Percentage of patients with a normal value of LDL cholesterol, HDL cholesterol and triglycerides on D45 Clinical and biological safety parameters of rosuvastatin and pravastatin Distribution profile of the diameter of LDL cholesterol particles Cmin of rosuvastatin and pravastatin on D15 Cmin of protease inhibitors on D15.
Detailed description:
The study compares the efficacy and safety of rosuvastatin and pravastatin among dyslipidemic
HIV-seropositive patients treated with antiretroviral agents including a boosted protease
inhibitor.
It is an open, multicenter, randomised trial, with two parallel groups comparing rosuvastatin
with pravastatin.
Statins are administered from D0, with a single daily dose in the morning, for 45 consecutive
days.
The duration of the study for each patient will be 45 days not including the preselection
period (maximum 15 days).
The primary end-point compares the change in LDL cholesterol between D0 and D45, in patients
receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral
agents including a boosted Protease Inhibitor.
Secondary end-points compares changes in triglycerides and HDL cholesterol; percentage of
patients with a normal value of LDL cholesterol, HDL cholesterol and triglycerides on D45;
clinical safety and laboratory safety parameters of rosuvastatin and pravastatin;
distribution profile of the diameter of LDL cholesterol particles.
Cmin of rosuvastatin, pravastatin and protease inhibitors (PI) are controlled at D15 for
statins and PI.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
service de Médecine Interne Hopital Hotel Dieu, Paris 75004, France
Additional Information
Starting date: October 2005
Ending date: June 2007
Last updated: February 6, 2008
|
