HIV Infection, HIV Infections
Conditions
Keywords
maraviroc, immune restoration, treatment intensification
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.
Interventions
DRUGmaraviroc
maraviroc 150 mg or 300 mg or 600 mg twice a day for 24 weeks
Sponsors
French National Agency for Research on AIDS and Viral Hepatitis
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLise CUZIN, MD
CHU Purpan - Toulouse (France)
Outcome results
None listed