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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Infection HIV Infections Drug: maraviroc Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2009
Primary Completion Date : August 2010
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: maraviroc
    maraviroc 150 mg or 300 mg or 600 mg twice a day for 24 weeks
    Other Name: Celsentri

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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): NCT00944541

French National Agency for Research on AIDS and Viral Hepatits
Paris, France, 75013
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Principal Investigator: Lise CUZIN, MD CHU Purpan - Toulouse (France)
More Information

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00944541     History of Changes
Other Study ID Numbers: 2009-011171-76
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: December 22, 2011
Last Verified: December 2011

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
immune restoration
treatment intensification

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents