Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) - Full Text View

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

MedlinePlus related topics: AIDS Cholesterol Statins

Drug Information available for: Pravastatin Pravastatin sodium Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

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

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

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 Measures:

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)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117494

Locations

France
service de Médecine Interne Hopital Hotel Dieu
Paris, France, 75004

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

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:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00117494
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

Hyperlipidemia
HIV infections
STATINS, HMG-COA
Protease Inhibitor
Treatment Experienced

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Hyperlipidemias
Metabolic Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Pravastatin

Rosuvastatin
HIV Infections
Sexually Transmitted Diseases
Metabolic disorder
Retroviridae Infections
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Infection
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 14, 2009