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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 2

Conditions: HIV Infection; HIV Infections

Treatments: Drug: maraviroc

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00944541

ANRS 145 MARIMUNO

2009-011171-76

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)