Virologic efficacy of Maraviroc in adult naive HIV patients with HIV-RNA>= 1000 copies/ml - ND

INTERVENTION: 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 Pharmaceutical Form: Tablet INN or Proposed INN: EMTRICITABINA/TENOFOVIR DISOPROXIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: KALETRA Pharmaceutical Form: Capsule, soft INN or Proposed INN: LOPINAVIR CAS Number: 192725‐17‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 133‐ INN or Proposed INN: RITONAVIR CAS Number: 155213‐67‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 133‐ CONDITION: naive HIV affected patients ; MedDRA version: 9.1 Level: LLT Classification code 10000811 Term: Acute infection with HIV PRIMARY OUTCOME: 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. 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. 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 < 4 weeks and none in the 8 weeks preceding randomization. ‐ A CD4 cell count of ≥ 100 cells/mmc at Screening. ‐ HIV‐RNA≥ 1000 copies/ml at Screening. ‐ Platelet count must be ≥ 75000/L, hemoglobin ≥ 9 g/dL, serum creatinine < 2 mg/dL, and AST and ALT ≤ 3 x ULN at Screening. ‐ Subjects must have given written informed consent and must be able to adhere to dose and visit schedules. ‐ Female subjects of child‐bearing potential must agree to use a medically accepted method of contraception. ‐ Female subjects of child‐bearing potential must have a negative serum beta‐hCG pregnancy test at Screening, and a negative urine beta‐HCG pregnancy test on Day 1 prior to dosing. Are the trial subjects under 18? no<