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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00117494
First received: June 30, 2005
Last updated: December 21, 2011
Last verified: December 2011

June 30, 2005
December 21, 2011
October 2005
March 2007   (final data collection date for primary outcome 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.
Same as current
Complete list of historical versions of study NCT00117494 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)
Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperlipidemia
  • HIV Infections
  • Drug: Pravastatin
  • Drug: Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
June 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00117494
2005-001451-38, ANRS 126
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Elisabeth Aslangul, MD Hopital Hôtel Dieu Paris
Study Director: Dominique Costagliola Inserm U720 Paris Pitié Salpétrière
French National Agency for Research on AIDS and Viral Hepatitis
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP