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

NCT00117494 | Completed Phase 4

• 2 other identifiers: 2005-001451-38ANRS 126
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperlipidemia; HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

Interventions

Pravastatin DRUG

Rosuvastatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Coronary disease
• Genetic muscular disease
• CPK over 5N
• Hepatic or renal insufficiency
• Alcohol intake more than 40g/d
• Hypothyroidism
• Pregnancy and breast feeding

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

service de Médecine Interne Hopital Hotel Dieu

Paris, 75004, France

Location

Related Publications (2)

• Bittar R, Giral P, Aslangul E, Assoumou L, Valantin MA, Kalmykova O, Federspiel MC, Cherfils C, Costagliola D, Bonnefont-Rousselot D; French National Agency for AIDS and Viral Hepatitis Research (ANRS) 126 study group. Effects of rosuvastatin versus pravastatin on low-density lipoprotein diameter in HIV-1-infected patients receiving ritonavir-boosted protease inhibitor. AIDS. 2012 Sep 10;26(14):1801-5. doi: 10.1097/QAD.0b013e328357063c.

  PMID: 22739396 DERIVED

• Bittar R, Giral P, Aslangul E, Assoumou L, Valantin MA, Kalmykova O, Fesel-Fouquier V, Costagliola D, Bonnefont-Rousselot D; ANRS 126 study group. Determinants of low-density lipoprotein particle diameter during antiretroviral therapy including protease inhibitors in HIV-1-infected patients. Antivir Ther. 2012;17(5):855-60. doi: 10.3851/IMP2065. Epub 2012 Feb 9.

  PMID: 22318219 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; HIV Infections

Interventions

Pravastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Elisabeth Aslangul, MD

  Hopital Hôtel Dieu Paris

  PRINCIPAL INVESTIGATOR

• Dominique Costagliola

  Inserm U720 Paris Pitié Salpétrière

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 7, 2005
• Study Start: October 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: June 1, 2007
• Last Updated: December 22, 2011

Record last verified: 2011-12

Locations

FR (1)