Trial record 10 of 30 for:    " December 23, 2012":" January 22, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor:
Collaborator:
Sidaction
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier:
NCT01874743
First received: December 26, 2012
Last updated: June 11, 2013
Last verified: December 2012
  Purpose

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 Intervention Phase
HIV-1 Infection
Drug: Rosuvastatin 20 mg/day
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:

Primary Outcome Measures:
  • CD8 T cell activation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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

  • Coexpress activation markers [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    proportion of peripheral CD8 T cells that co-express the activation markers CD38 and HLA-DR


Secondary Outcome Measures:
  • Rosuvastatin administration (on and off)on biomarkers activation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • 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

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

  • CD4 T-cell count and on the CD4/CD8 T-cell ratio [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    • 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

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

  • Tolerance of Rosuvastatine [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To evaluate the tolerance of Rosuvastatin at the dose of 20 mg/day (Number of patients with adverse events grade > 2)


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874743

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

Locations
France
HEGP Recruiting
Paris, France, 75015
Contact: Laurence Weiss, PHD,MD    56093299 ext +331    laurence.weiss@egp.aphp.fr   
Principal Investigator: Laurence Weiss, PHD,MD         
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         
Sponsors and Collaborators
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sidaction
Investigators
Principal Investigator: Laurence Weiss, PH,MD HEGP
  More Information

No publications provided

Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier: NCT01874743     History of Changes
Other Study ID Numbers: IMEA 043 CESAR
Study First Received: December 26, 2012
Last Updated: June 11, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
HIV,
Rosuvastatine,
Antiretroviral therapy

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014