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

OSPEDALE S. RAFFAELE0 个研究点开始时间: 2009年3月17日最近更新: 2012年3月19日

研究概览

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•- 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
•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

•- 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.

发起方

OSPEDALE S. RAFFAELE