naive HIV affected patients MedDRA version: 9.1 Level: LLT Classification code 10000811 Term: Acute infection with HIV
Conditions
Interventions
Trade Name: CELSENTRI
Pharmaceutical Form: Tablet
INN or Proposed INN: MARAVIROC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: TRUVADA
Pharmace
Sponsors
OSPEDALE S. RAFFAELE
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 with CCR5-tropic HIV infection. - Cumulative lifetime antiretroviral therapy exposure of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Female subjects of childbearing potential who are breatfeeding, 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. - CXCR4 or dual-mixed (CXCR4 and CCR5) tropism. - Subjects with primary resistance mutations to any of proposed components of the study arms. - 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 patecipation. - Subjects with allergy/sensitivity to study drug or its excipients. - Subjects who are participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the long-term efficacy and tolerability of MVC, to assess the increase of CD4 cells and to explore the relationship of plasma drug concentrations (pharmacokinetics) to virologic response.;Main Objective: To evaluate the virologic efficacy of Maraviroc (MVC) in term of decrease of HIV-DNA (proviral) and HIV-RNA plasma kinetic decay combined with Kaletra in HIV-1 infected treatment subjects.;Primary end point(s): To evaluate the virologic efficacy of Maraviroc (MVC) in term of decrease of HIV-DNA (proviral) and HIV-RNA plasma kinetic decay combined with Kaletra in HIV-1 infected treatment subjects. | — |
Countries
Italy
Outcome results
None listed