Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration (145 MARIMUNO)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00944541
First received: July 22, 2009
Last updated: December 21, 2011
Last verified: December 2011

July 22, 2009
December 21, 2011
September 2009
August 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00944541 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infection
  • HIV Infections
Drug: maraviroc
maraviroc 150 mg or 300 mg or 600 mg twice a day for 24 weeks
Other Name: Celsentri
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2011
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00944541
2009-011171-76, ANRS 145 MARIMUNO
Yes
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
Pfizer
Principal Investigator: Lise CUZIN, MD CHU Purpan - Toulouse (France)
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