Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration
NCT00944541
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- 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
- 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
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Descriptive Information | ||||
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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 |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |