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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-01-31

Brief Summary

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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

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Conditions

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HIV Infection HIV Infections

Keywords

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maraviroc immune restoration treatment intensification

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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maraviroc

maraviroc 150 mg or 300 mg or 600 mg twice a day for 24 weeks

Intervention Type DRUG

Other Intervention Names

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Celsentri

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lise CUZIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Purpan - Toulouse (France)

Locations

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French National Agency for Research on AIDS and Viral Hepatits

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ANRS 145 MARIMUNO

Identifier Type: -

Identifier Source: secondary_id

2009-011171-76