Vicriviroc in Combination Treatment with Optimized ART Regimen in Experienced Subjects (VICTOR-E1) - VICTOR-E1

Schering-Plough Research Insititute, a division of Schering Corporation0 个研究点目标入组 120 人开始时间: 2005年9月14日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Adult subjects with documented HIV infection with R5-only tropism.
•Prior therapy for at least 3 months with at least 3 classes of currently marketed (US FDA-approved) antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening.
•HIV RNA level of at least 1000 copies/mL on a stable ART regimen for at least 6 weeks
•At least 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and at least 1 primary resistance mutation to a PI
•Acceptable hematologic, renal and hepatic laboratory parameters
•QTc internal less than 470 msec (female) and less than 450 msec male
•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

•Detectable X4 or R5/X4 virus
•History of recurrent seizure of CNS condition that may predispose the subject to seizure
•Active AIDS defining opportunistic infection
•Prior history of malignancy (with the exceptions of cutaneous Kaposi's sarcoma that resolved with HAART but without systemic anticancer treatment); or prior receipt of cytotoxic cancer chemotherapy that may increase the risk of malignancy
•Known liver cirrhosis, or clinical symptoms, signs or laboratory abnormalities consistent with cirrhosis

发起方

Schering-Plough Research Insititute, a division of Schering Corporation