EUCTR2006-006417-32-GB进行中（未招募）1 期
Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4) - VICTOR-E4
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 375
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. A subject must give written informed consent prior to screening for this study
- •2. A subject must be willing and able to adhere to dose and visit schedules
- •3. A subject must be at least 16 years of age (or minimum age that defines an adult as determined by local regulatory authorities or legal requirements) at the time of randomization, of either sex, and of any race
- •4. A subject must be infected with HIV-1 virus, as documented by a positive assay for HIV-1 RNA in plasma, prior to Screening
- •5. A subject must have plasma HIV-1 RNA >1000 copies/mL within 60 days of
- •randomization, either
- •a) on a stable regimen of 3 or more antiretroviral drugs for at least 4 weeks at time of Screening, OR
- •b) on no antiretroviral agents, for =4 weeks prior to Screening
- •6. Subjects must be ART-experienced and have documented resistance (as determined by the Monogram GeneSEq or PhenoSense HIV Drug Resistance assay) to at least 2 of the following 3 drug classes: NRTI, NNRTI or PI
- •Antiretroviral class experience =6 months (sequential or cumulative) with at least two of the following:
- •a) one NRTI
- •b) one NNRTI
- •c) two PIs (excluding low dose ritonavir)
- •7. Subjects must be willing to begin newly optimized background therapy (OBT) containing at least 3 drugs at time of randomization, one of which must be a ritonavir-boosted PI. The OBT must contain at least 2 active drugs
- •Note: If tipranavir is used as part of a subject’s OBT, liver function tests must be
- •performed at initiation of therapy and monitored frequently throughout the duration of treatment. Subjects must be followed closely and investigators must be vigilant for the appearance of signs or symptoms of hepatitis, such as fatigue, malaise, anorexia, nausea, jaundice, bilirubinemia, acholic stools, and liver tenderness, especially in those with liver enzyme abnormalities or history of chronic liver disease. Tipranavir should not be given to subjects with moderate to severe liver disease
- •8. QTc interval (corrected by the Bazett method) read by the Central EKG Cardiologist must be <470 msec for female subjects and <450 msec for male subjects
- •9. Subjects must have acceptable hematologic, renal, and hepatic laboratory parameters: Platelet count =75,000/µL; hemoglobin =9.0 g/dL; absolute neutrophil count =750/µL; serum creatinine =2 x ULN; AST (SGOT) and ALT (SGPT) =5 x ULN; alkaline phosphatase =5 x ULN; total bilirubin =2.5 x ULN. For subjects receiving indinavir or atazanavir, or known to have Gilbert’s syndrome, the total bilirubin must be =5 x ULN and in fractionation must demonstrate that the increase is due to an elevated indirect bilirubin. Subjects with chronic hepatitis B or C may be enrolled if they have stable liver disease and liver enzymes in the following ranges: AST (SGOT) and ALT (SGPT) =3 x ULN; alkaline phosphatase =5 x ULN; total bilirubin =2.5 x ULN
- •10. Women of child-bearing potential must agree to use a medically accepted method of contraception prior to receiving protocol-specified medication, and for 2 months after stopping the medication. Acceptable methods include:
- •a. condoms (male or female), with or without a spermicidal agent (Note: i
排除标准
- •1) Subjects must not have detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates at Screening (i.e. HIV isolate must be solely CCR5-tropic)
- •2) Subjects must not have any condition that, in the opinion of the investigator, is likely to increase the risk of seizures
- •3) Subjects must not have a prior history of malignancy (with the exceptions of surgically resected basal-cell carcinoma or cutaneous Kaposi's sarcoma without visceral or mucosal inlvolement that resolved without systemic anticancer treatment)
研究者
相似试验
进行中（未招募）
不适用
Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4) - VICTOR-E4HIV infection (R5 tropism only) with previous therapyMedDRA version: 9.1Level: LLTClassification code 10200172Term: <Manually entered code. Term in E.1.1>EUCTR2006-006417-32-PTSchering-Plough Research Institute375
进行中（未招募）
不适用
Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4). - VICTOR E4EUCTR2006-006417-32-ITSchering Plough Research Institute375
已完成
不适用
Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced SubjectsPER-068-07SCHERING PLOUGH DEL PERU S.A.,
进行中（未招募）
不适用
Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4) - VICTOR-E4HIV infection (R5 tropism only) with previous therapyMedDRA version: 9.1Level: LLTClassification code 10200172Term: <Manually entered code. Term in E.1.1>EUCTR2006-006417-32-DESchering-Plough Research Institute375
进行中（未招募）
1 期
Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4) - VICTOR-E4EUCTR2006-006417-32-FRSchering-Plough Research Institute375