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Trial record 1 of 1 for:    NCT00944541
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Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration (145 MARIMUNO)

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ClinicalTrials.gov Identifier: NCT00944541
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : December 22, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis

Tracking Information
First Submitted Date  ICMJE July 22, 2009
First Posted Date  ICMJE July 23, 2009
Last Update Posted Date December 22, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load [ Time Frame: immunologic benefit at week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2009)
Maraviroc efficacy at W24 (virological and immunological efficacy); Durability of maraviroc efficacy between W24 & W36; Cmin of maraviroc and other molecules at W4,12,24; Evaluation of the safety of maraviroc between W0 and W36. [ Time Frame: immuno-virologic evolution between week 0 and week 36 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration
Official Title  ICMJE Pilot Study Evaluating Maraviroc (Celsentri®)Intensification Benefit in HIV Infected Patients Presenting Insufficient Immune Restoration Despite Controlled Viral Load With Antiretroviral Treatment. ANRS 145 MARIMUNO
Brief Summary

This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL during last 24 months).

The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infection
  • HIV Infections
Intervention  ICMJE Drug: maraviroc
maraviroc 150 mg or 300 mg or 600 mg twice a day for 24 weeks
Other Name: Celsentri
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV-1 infection
  • maraviroc-naives patients
  • CD4 less than 350 cells/mm3
  • viral load less than 50 cp/mL and CD4 earning less than 100 cells/mm3 during last 24 months

Exclusion Criteria:

  • HIV-2 infection
  • X4 tropism at inclusion
  • pregnancy and breast feeding
  • interferon, immunomodulatory drugs treatment or anti-HIV vaccines and chemotherapy
  • hypersensibility of peanut or soya
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00944541
Other Study ID Numbers  ICMJE 2009-011171-76
ANRS 145 MARIMUNO
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party French National Agency for Research on AIDS and Viral Hepatitis
Study Sponsor  ICMJE French National Agency for Research on AIDS and Viral Hepatitis
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Lise CUZIN, MD CHU Purpan - Toulouse (France)
PRS Account French National Agency for Research on AIDS and Viral Hepatitis
Verification Date December 2011

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