Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperlipidemia HIV Infections |
Drug: Pravastatin Drug: Rosuvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126 |
- 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.
- Changes in triglycerides and HDL cholesterol on D45
- 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
- Distribution profile of the diameter of LDL cholesterol particles
- Cmin of rosuvastatin and pravastatin on D15
- Cmin of protease inhibitors on D15.
| Estimated Enrollment: | 86 |
| Study Start Date: | October 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| service de Médecine Interne Hopital Hotel Dieu | |
| Paris, France, 75004 | |
| Principal Investigator: | Elisabeth Aslangul, MD | Hopital Hôtel Dieu Paris |
| Study Director: | Dominique Costagliola | Inserm U720 Paris Pitié Salpétrière |
More Information
No publications provided by French National Agency for Research on AIDS and Viral Hepatitis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00117494 History of Changes |
| Other Study ID Numbers: | 2005-001451-38, ANRS 126 |
| Study First Received: | June 30, 2005 |
| Last Updated: | December 21, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
Hyperlipidemia HIV infections STATINS, HMG-COA Protease Inhibitor Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hyperlipidemias Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
Protease Inhibitors Pravastatin Rosuvastatin Anti-Retroviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on March 03, 2013
