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| Sponsored by: |
French National Agency for Research on AIDS and Viral Hepatitis |
|---|---|
| Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00117494 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126 |
| 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:
Exclusion Criteria:
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
| Responsible Party: | ANRS ( MJ Commoy/ regulatory affairs sponsor ) |
| Study ID Numbers: | 2005-001451-38, ANRS 126 |
| Study First Received: | June 30, 2005 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00117494 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Hyperlipidemia HIV infections STATINS, HMG-COA Protease Inhibitor Treatment Experienced |
|
Antimetabolites Sexually Transmitted Diseases, Viral Hyperlipidemias Metabolic Diseases Antilipemic Agents Acquired Immunodeficiency Syndrome Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Immunologic Deficiency Syndromes Protease Inhibitors |
Virus Diseases Pravastatin Rosuvastatin Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
|
Antimetabolites Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Pravastatin Rosuvastatin Therapeutic Uses Retroviridae Infections Dyslipidemias RNA Virus Infections Hyperlipidemias Metabolic Diseases Immune System Diseases |
Antilipemic Agents Acquired Immunodeficiency Syndrome Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Lipid Metabolism Disorders |
