HIV MedDRA version: 9.1 Level: HLT Classification code 10052740
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Maraviroc
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 150-
Sponsors
AZIENDA OSPEDALIERA "OSPEDALI RIUNITI DI BERGAMO" (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i. Age > 18 years ii. Informed consent signed (add. 1) iii. Patients with a reduced CD4 cell count (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours ii. Any ongoing grade 4 (WHO) AE or laboratory abnormality. iii. Allergy/intolerance to the study drug iv. Treatment with immunomodulatory agents v. Treatment with steroids vi. Radiotherapy or chemotherapy vii. HAART consisting of a combination of tenofovir and didanosine viii. Autoimmune disorder or chronic inflammatory disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To verify if adding maraviroc to an effective HAART induces the increase of the CD4 cell count.;Secondary Objective: ? Evaluation of long-term safety and tolerability ? Assessment of the durability of viro-immunologic responses;Primary end point(s): The study is powered to demonstrate superiority of maraviroc-based therapy in term of immunological recovery. The evaluation will be based on an AT (as treated) approach and will be defined as an increase of at least 50 cells/mmc compared to the respective baseline value after 6 months of therapy. Sample size has been defined on this end-point. The secondary end-points will have an exploratory meaning. | — |
Countries
Italy
Outcome results
None listed