Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects

SCHERING PLOUGH DEL PERU S.A.,0 个研究点目标入组 0 人开始时间: 2007年10月31日最近更新: 2023年9月4日

研究概览

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•The subject must be at least 16 years of age (or the minimum age determined by the local regulatory authorities) at the time of randomization and be of any sex and age.
•The subject must be infected with the HIV-1 virus, confined by a positive analysis of HIV-1 RNA in plasma, prior to the selection stage.
•The subject must submit> 1000 copies / ml of HIV-1 RNA in plasma within 60 days prior to randomization, either: a. with a stable regimen of 3 or more antiretroviral agents for at least 4 weeks at the time of selection. b. without treatment with antiretroviral agents, for> 4 weeks before the Selection.
•Subjects must have received ART and have confirmed resistance (determined by the HIV Monogram GeneSEq or PhenoSense drug resistance assay) to at least 2 of the following 3 classes of drugs; NRTI, NNRTI or IP OR have been treated for at least 6 months (consecutive or cumulative) with each of the following classes: NRTI, NNRTI, IP.

•Subjects should not present tropic HIV strains to CXCR4 or dual / mixed tropism CCR5 / CXCR4 in the Selection stage (ie, that the HIV strain should only be tropic to CCR5).
•Subjects must not present any condition that, in the opinion of the investigator, may increase the risk of seizures.
•Subjects should not have a history of cancer (with the exception of surgically excised basal cell carcinoma or Kaposi´s sarcoma without visceral or mucosal involvement that would have resolved without systemic antineoplastic therapy).

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