se of Maraviroc (MVC) in immunogical non-responder HIV-1-infected patients. - ND
- Conditions
- HIV-1-infected HAART-treated patients that reached a virologic suppression without a reconstitution of their immune system.MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection
- Registration Number
- EUCTR2008-002661-30-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
HIV+ patients (aged 18 yrs or older) with a CD4 count ≤ 200 cells/uL and/or a recovery of CD4 cells < 25% compared to the HAART initiation and/or a stable CD4 slope without any improvement, with an absolute value around 200 cells/uL and with a complete and stable virologic suppression after 12 months of HAART.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Intolerance to Maraviroc (MVC); treatment with immunomodulant agents; chronic inflammatory diseases; biochemical toxicity of grade 3-4.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method