HIV-1-infected HAART-treated patients that reached a virologic suppression without a reconstitution of their immune system. MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Product Name: Maraviroc
Pharmaceutical Form: Tablet
Other descriptive name: Maraviroc
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HIV+ patients (aged 18 yrs or older) with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Intolerance to Maraviroc (MVC); treatment with immunomodulant agents; chronic inflammatory diseases; biochemical toxicity of grade 3-4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clinical efficacy, influence on viro-immunological paramethers and tolerability of Maraviroc (MVC)in HIV+ patients with CD4+ lymphocytes ≤200 cell/uL and/or with recovery of CD4+ lymphocytes ≤25%.;Secondary Objective: Efficacy of Maraviroc (MVC) on immunological paramethers.;Primary end point(s): At 3 and 12 months from baseline: CD4 lymphocytes >200 cell/uL and recovery of CD4 lymphocytes >25%, being maintained a value of HIV-RNA <50 copies/mL. | — |
Countries
Italy
Outcome results
None listed