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

Primary Purpose

HIV Infection, HIV Infections

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
maraviroc
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring maraviroc, immune restoration, treatment intensification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • French National Agency for Research on AIDS and Viral Hepatits

Outcomes

Primary Outcome Measures

Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load

Secondary Outcome Measures

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.

Full Information

First Posted
July 22, 2009
Last Updated
December 21, 2011
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00944541
Brief Title
Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration
Acronym
145 MARIMUNO
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, HIV Infections
Keywords
maraviroc, immune restoration, treatment intensification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
maraviroc
Other Intervention Name(s)
Celsentri
Intervention Description
maraviroc 150 mg or 300 mg or 600 mg twice a day for 24 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise CUZIN, MD
Organizational Affiliation
CHU Purpan - Toulouse (France)
Official's Role
Principal Investigator
Facility Information:
Facility Name
French National Agency for Research on AIDS and Viral Hepatits
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

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Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration

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