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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Pfizer
• Treatments: Maraviroc

Criteria

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