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Rosuvastatin to Decrease Residual Immune Activation in HIV Infection (CESAR)

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ClinicalTrials.gov Identifier: NCT01874743
Recruitment Status : Unknown
Verified December 2012 by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba.
Recruitment status was:  Recruiting
First Posted : June 11, 2013
Last Update Posted : June 12, 2013
Sponsor:
Collaborator:
Sidaction
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Brief Summary:
Participating countries: France Objectives Principal objective To evaluate, in HIV-1 infected patients receiving effective antiretroviral therapy, the effect of the addition of Rosuvastatin (dose of 20mg/day) for 3 months, on CD8 T cell activation as assessed by the proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR Secondary objectives To evaluate the effect of Rosuvastatin administration on residual CD4 and CD8 T cell activation To evaluate the effect of Rosuvastatin administration on the main serum soluble biomarkers of activation (CRP- HS, D-dimers, IL-6 and soluble CD14) To evaluate the effect of Rosuvastatin administration on CD4 T-cell count and on the CD4/CD8 T-cell ratio To study the relationship between the level of immune activation and the level of residual HIV replication in plasma To study the effect of Rosuvastatin administration on lipid profiles and the correlation between the HDL cholesterol and the CD4/CD8 T-cell ratio To evaluate the tolerance of Rosuvastatin at the dose of 20 mg/day

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Rosuvastatin 20 mg/day Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pilot Study of the Impact of Rosuvastatin Administration on Residual Chronic Immune Activation Under Antiretroviral Therapy: CESAR (Crestor En Sus Des AntiRétroviraux)
Study Start Date : March 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Rosuvastatine 20 mg
Rosuvastatin 20 mg/day, once a day during 3 months
Drug: Rosuvastatin 20 mg/day
All patients must take 20mg/day of rosavastatin during 3 months
Other Name: Crestor ,(ZD 4522)




Primary Outcome Measures :
  1. CD8 T cell activation [ Time Frame: 6 months ]
    To evaluate, in HIV-1 infected patients receiving effective antiretroviral therapy, the effect of the addition of Rosuvastatin (dose of 20mg/day) for 3 months, on CD8 T cell activation as assessed by the proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR

  2. Coexpress activation markers [ Time Frame: 6 months ]
    proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR


Secondary Outcome Measures :
  1. Rosuvastatin administration (on and off)on biomarkers activation [ Time Frame: 6 months ]
    • Changes from baseline to month 3 (on rosuvastatin) and from month 3 to month 6 (off rosuvastatin) in levels of CRP-HS, IL-6, soluble CD14 Changes from baseline to month 3 (on rosuvastatin) and from month 3 to month 6 (off rosuvastatin) in the proportion of CD4 T cells expressing HLA-DR or Ki67 activation markers and in the proportion of CD8 T cells expressing HLA-DR and/or CD38 or Ki67 activation marker

  2. Relationship between the levels of T-cell activation and of plasma HIV-RNA (ultrasensible measure) [ Time Frame: 6 months ]
    • Relationship between the levels of T-cell activation and of plasma HIV-RNA levels at a detection level of 3 copies/mL

  3. CD4 T-cell count and on the CD4/CD8 T-cell ratio [ Time Frame: 6 months ]
    • Changes in CD4 T-cell count between baseline and month 3 •
    • Changes in the CD4/CD8 ratio between baseline and month 3 and between month 3 and month 6

  4. Lipids profiles on and off rosuvastatine association [ Time Frame: 6 months ]
    • Changes from baseline to month 3 (on rosuvastatin) and from month 3 to month 6 (off rosuvastatin) in levels of HDL and LDL cholesterol

  5. Tolerance of Rosuvastatine [ Time Frame: 6 months ]
    To evaluate the tolerance of Rosuvastatin at the dose of 20 mg/day (Number of patients with adverse events grade > 2)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected patients receiving a combination of antiretroviral therapy for at least 24 months, unchanged since at least 18 months, exhibiting plasma HIV-RNA level below 20 copies and circulating CD4 T cell count below 500/mm3
  • No indication for a treatment with statins (LDL cholesterol < 4.1 mmol/L under stable diet).

Exclusion Criteria:

  • Patients receiving Maraviroc
  • Patients receiving immune suppressing drugs
  • Ongoing opportunistic, bacterial or viral infection
  • CRP ≥ 10 mg/mL
  • Co-infection with HCV (except if HCV cure), chronic HBV infection with active replication of HBV
  • Indication for a treatment with statins
  • Pregnancy
  • CPK > 3x Normal values
  • ALT or AST > 2x Normal values
  • TG > 4 mmol/L
  • DFG < 60 mL /min/1.73 m2
  • Personal or familial history of genetic muscular disease
  • History of muscular or hepatic toxicity with a statin or a fibrate
  • Liver disease (TP < 70%).
  • Hypothyroidism
  • Concomitant treatment with : Kétoconazole, Itraconazole, Ciclosporine, Erythromycine, Cimétidine, Quinidine, Diltiazem, Vérapamil, systemic corticosteroids, Phénobarbital, Phénytoïne, Carbamazépine, Rifampicine, Lansoprazole
  • Vaccination during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874743


Contacts
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Contact: Laurence Weiss, PH,MD 56093299 ext +331 laurence.weiss@egp.aphp.fr

Locations
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France
St Antoine Hospital Recruiting
Paris, France, 75012
Contact: pauline Campa, MD    49283044 ext +331    pauline.campa@sat.aphp.fr   
Principal Investigator: Pierre-Marie Girard, PHD,MD         
HEGP Recruiting
Paris, France, 75015
Contact: Laurence Weiss, PHD,MD    56093299 ext +331    laurence.weiss@egp.aphp.fr   
Principal Investigator: Laurence Weiss, PHD,MD         
Sponsors and Collaborators
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sidaction
Investigators
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Principal Investigator: Laurence Weiss, PH,MD HEGP
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Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier: NCT01874743    
Other Study ID Numbers: IMEA 043 CESAR
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: December 2012
Keywords provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
HIV,
Rosuvastatine,
Antiretroviral therapy
Additional relevant MeSH terms:
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Infection
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors