Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects

Schering-Plough Research Institute0 个研究点目标入组 80 人开始时间: 2007年12月20日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Adult subjects (=18 years or minimum age that defines an adult as determined by local regulatory authorities or legal requirements) of either sex or any race with CCR5-tropic HIV infection.
•2. Cumulative lifetime anti-retroviral therapy exposure of =4 weeks and none in the 8 weeks preceding randomization.
•3. A CD4 cell count of =200 cell/mm3 at Screening.
•4. HIV RNA must be =5000 copies/mL at Screening.
•5. Subjects should meet IAS, DHSS, or local recommendations for initiation of ART.
•6. Platelet count must be =75,000/µL, hemoglobin =9 g/dL, absolute neutrophil count =1500/µL, serum creatine <2.0 mg/dL (154 µmol/L), and SGOT/SGPT =3 x ULN at Screening. Other clinical laboratory tests must be within normal limits or clinically acceptable to the investigator.
•7. Female subjects of childbearing potential must be using a medically accepted method of birth control prior to Screening and agree to continue its use during the study, or must have been surgically sterilized.
•8. Female subjects of childbearing potential must have a negative serum beta-hCG (human chorionic gonadotropin) pregnancy test at Screening and a negative urine beta-hCG pregnancy test on Day 2 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

•1. Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant.
•2. Subjects with intercurrent illness, vaccinations, or who have used immunomodulators (within the 4-week period prior to randomization) that could influence plasma HIV RNA levels.
•3. CXCR4 or dual-mixed (CXCR4 and CCR5) tropism.
•4. Subjects with primary resistance mutations to any of proposed components of the study arms.
•5. Subjects with active opportunistic infection or malignancy.
•6. 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 for seizures.

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