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

French National Agency for Research on AIDS and Viral Hepatitis60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infection HIV Infections

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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