HIV infection MedDRA version: 9.1 Level: LLT Classification code 10008922
Conditions
Interventions
Trade Name: CELSENTRI
Pharmaceutical Form: Tablet
INN or Proposed INN: MARAVIROC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must be at least 18 years of age at the time of randomization, of either sex and of any race. - Treatment-experienced subjects. - Failing current antiretroviral therapy (HAART). - Genotyping sensitivity score (GSS)>1. - HIV-RNA≥ 500 copies/ml at Screening. - Platelet count must be ≥ 75000/mL, hemoglobin ≥ 9 g/dL, serum creatinine =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant. - Subjects with active opportunistic infection or malignancy. - Subjects with intercurrent illness, vaccinations, or who have used immunomodulators that could influence plasma HIV-RNA levels within the 4-week period prior the randomization. - Subjects with seizure disorder requiring ongoing anti-seizure therapy or with a history of a seizure disorder who are, in the judgment of the investigator, at risk of seizures. - Subjects with known liver cirrhosis. - Subjects with any clinically significant condition or situation other than the condition being studied that, in the opinion of investigator, would interfere with the study evaluations or optimal participation. - Subjects with allergy/sensitivity to drugs or its excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the 48-weeks virological response in patients who started an antiretroviral treatment including Maraviroc following the genotypic or the Trofile assay.;Secondary Objective: -Immunological and clinical efficacy. -Number of subjects with an undetermined result among the two viral tropism assays.;Primary end point(s): This study will evaluate proportion of patients with undetectable viremia (HIV-RNA < 50 copies/mL) after 48 weeks of treatment with MVC+OBT. | — |
Countries
Italy
Outcome results
None listed