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

HIV Infections Clinical Trial

Official title:

Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00117494
• Other study ID #: 2005-001451-38
• Secondary ID: ANRS 126
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2005
• Last updated: December 21, 2011
• Start date: October 2005
• Est. completion date: June 2007

Study information

• Verified date: December 2011
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Pravastatin

• Rosuvastatin

Locations

Country	Name	City	State
France	service de Médecine Interne Hopital Hotel Dieu	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in triglycerides and HDL cholesterol on D45
Secondary	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
Secondary	Distribution profile of the diameter of LDL cholesterol particles
Secondary	Cmin of rosuvastatin and pravastatin on D15
Secondary	Cmin of protease inhibitors on D15.