Clinical trial NCT00117494: Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)
Official title: Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperlipidemia
HIV Infections
Keywords: Hyperlipidemia
HIV infections
STATINS, HMG-COA
Protease Inhibitor
Treatment Experienced
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
First posted: 2005-07-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: 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 outcomes:
measure: Changes in triglycerides and HDL cholesterol on D45
measure: Percentage of patients with a normal value of LDL cholesterol, HDL cholesterol and triglycerides on D45 Clinical and biological safety parameters of rosuvastatin and pravastatin
measure: Distribution profile of the diameter of LDL cholesterol particles
measure: Cmin of rosuvastatin and pravastatin on D15
measure: Cmin of protease inhibitors on D15.
Other outcomes:
Locations:
city: Paris
country: France
facility: service de Médecine Interne Hopital Hotel Dieu
Study officials:
affiliation: Hopital Hôtel Dieu Paris
name: Elisabeth Aslangul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inserm U720 Paris Pitié Salpétrière
name: Dominique Costagliola
role: STUDY_DIRECTOR
References:
citation: Bittar R, Giral P, Aslangul E, Assoumou L, Valantin MA, Kalmykova O, Federspiel MC, Cherfils C, Costagliola D, Bonnefont-Rousselot D; French National Agency for AIDS and Viral Hepatitis Research (ANRS) 126 study group. Effects of rosuvastatin versus pravastatin on low-density lipoprotein diameter in HIV-1-infected patients receiving ritonavir-boosted protease inhibitor. AIDS. 2012 Sep 10;26(14):1801-5. doi: 10.1097/QAD.0b013e328357063c.
citation: Bittar R, Giral P, Aslangul E, Assoumou L, Valantin MA, Kalmykova O, Fesel-Fouquier V, Costagliola D, Bonnefont-Rousselot D; ANRS 126 study group. Determinants of low-density lipoprotein particle diameter during antiretroviral therapy including protease inhibitors in HIV-1-infected patients. Antivir Ther. 2012;17(5):855-60. doi: 10.3851/IMP2065. Epub 2012 Feb 9.