Maraviroc is an antiretroviral drug that belongs to the family of the CCR5 coreceptor inhibitors. It has proven to be effective in increasing CD4 lymphocyte counts in both in treated and naïve patients, irrespective of the viral load. The investigators hypothesize that adding Maraviroc to the antiretroviral treatment of discordant patients, defined as those having CD4 lymphocyte counts below 200 cells /mm3 during the last year, could lead to its immunological recovery. 60 patients will be included in this unicentric, prospective, randomized and stratified clinical trial. They will be randomized to either continue with its usual high activity antiretroviral therapy (HAART) treatment or to receive 300 mg of Maraviroc every 12 hours plus its usual treatment. After 24 weeks, lymphocyte counts will be assessed, as well as safety, clinical progression, immunological profile of the patients and the potential benefit of Maraviroc for HIV+ cirrhotic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks
Hospital Clínic i Provincial
Barcelona, Barcelona, Spain
Median of CD4 counts change after 24 weeks
Time frame: 24 weeks
Immunological profile
Immunohistochemistry and flow cytometry techniques will be performed on peripheral blood to study immunological response to Maraviroc treatment
Time frame: 24 weeks
CD4 counts
Number of pacients with CD4 counts over 200 cells/mm3
Time frame: 24 weeks
Clinical progression
Progression to diseases classified as category C in CDC HIV guidelines; to other diseases or patient death
Time frame: 24 weeks
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