Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3 (DIS-MVC)
Recruitment status was: Not yet recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3|
- Median of CD4 counts change after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Immunological profile [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Immunohistochemistry and flow cytometry techniques will be performed on peripheral blood to study immunological response to Maraviroc treatment
- CD4 counts [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Number of pacients with CD4 counts over 200 cells/mm3
- Clinical progression [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Progression to diseases classified as category C in CDC HIV guidelines; to other diseases or patient death
150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks
No Intervention: Control
Patients continue with their usual treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235013
|Hospital Clínic i Provincial|
|Barcelona, Spain, 08036|
|Principal Investigator:||José Luis Blanco, MD||Hospital Clínic i Provincial|