Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration
145 MARIMUNO
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
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedDecember 22, 2011
December 1, 2011
11 months
July 22, 2009
December 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load
immunologic benefit at week 24
Secondary Outcomes (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.
immuno-virologic evolution between week 0 and week 36
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- HIV-2 infection
- pregnancy and breast feeding
- interferon, immunomodulatory drugs treatment or anti-HIV vaccines and chemotherapy
- hypersensibility of peanut or soya
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
French National Agency for Research on AIDS and Viral Hepatits
Paris, 75013, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lise CUZIN, MD
CHU Purpan - Toulouse (France)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2009
First Posted
July 23, 2009
Study Start
September 1, 2009
Primary Completion
August 1, 2010
Study Completion
January 1, 2011
Last Updated
December 22, 2011
Record last verified: 2011-12