Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration
Phase 2
Completed
- Conditions
- HIV InfectionHIV Infections
- Registration Number
- NCT00944541
- Lead Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load immunologic benefit at week 24
- Secondary Outcome Measures
Name Time Method 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. immuno-virologic evolution between week 0 and week 36
Trial Locations
- Locations (1)
French National Agency for Research on AIDS and Viral Hepatits
🇫🇷Paris, France