Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 主要终点
- Percentage of Participants With ≥1 Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to provide open-label vicriviroc (VCV) to human immunodeficiency virus (HIV) treatment-experienced participants who successfully completed 48 weeks of treatment on Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) protocol A5211 (or who responded favorably to treatment but discontinued participation due to viral tropism shifts), and participants who screened for ACTG A5211 and met all inclusion/exclusion criteria, but were unable to enroll due to protocol closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful completion of ACTG Protocol A5211, or favorable response in A5211 but discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion criteria but unable to enroll due to protocol closure.
- •Participants must also be on a ritonavir-containing antiretroviral regimen at entry, and have acceptable hematologic and laboratory parameters.
- •Female participants of reproductive potential must agree to use 2 reliable methods of contraception, including a barrier method, and must have a negative urine pregnancy test prior to dosing.
排除标准
- •History of seizure or drug use that increases risk of seizure, current use of CYP3A4 inducers, prior history of malignancy, active drug or alcohol use or dependence that would interfere with study requirements
- •Female participants who are breast-feeding, pregnant, or plan to become pregnant
- •Participation in a clinical trial with another investigational drug.
- •Participants with serious illness requiring systemic therapy and/or hospitalization must not begin VCV (if not already on VCV) until participant completes therapy or is clinically stable on therapy for at least 14 days prior to enrollment.
研究组 & 干预措施
VCV 30 mg
Participants take VCV 30 mg once daily.
干预措施: Vicriviroc maleate (Drug)
结局指标
主要结局
Percentage of Participants With ≥1 Adverse Events (AEs)
时间窗: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Percentage of Participants Discontinuing Study Therapy Due to AEs
时间窗: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
时间窗: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
An SAE is any adverse occurrence that results in death; is life-threatening; results in a persistent disability; requires in-patient hospitalization or prolongs hospitalization; or is a congenital anomaly/birth defect.
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
时间窗: Every 12 months up to 60 months
The percentage of participants with HIV RNA \>50 to \<400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Number of Participants With Reduced Susceptibility to VCV
时间窗: Up to time of VF in P4100, assessed up to approximately 5.5 years
The total number of participants with viruses having phenotypic resistance to VCV is reported. Viruses exhibiting both maximum percent inhibition (MPI) plateau values of \<85% and relative MPI (R-MPI) values of \<0.9 (based on the PhenoSense HIV entry assay) were considered to have phenotypic resistance to VCV.
Number of Participants With AIDS-defining Events (ADEs)
时间窗: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
The number of participants with ADEs is reported. An ADE is an SAE that is expected in the course of disease and not considered related to study intervention. The sponsor identified events that met ADE criteria based on the 1993 Centers for Disease Control (CDC) Revised Classification System.
Number of Participants With New Infections
时间窗: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
The number of participants with new infections is reported.
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
时间窗: Every 12 months up to 60 months
The percentage of participants with HIV RNA \<50 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Percentage of Participants With HIV RNA ≥400 Copies/mL
时间窗: Every 12 months up to 60 months
The percentage of participants with HIV RNA ≥400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Number of Participants With Coreceptor Tropism Shifts From Baseline
时间窗: Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years
The number of participants with non reportable (NR) tropism, CCR5 (R5) tropism, or dual/mixed CCR5/CXCR4 (DM/X4) tropism at baseline, who had NR, R5, or DM/X4 tropism at the time of virologic failure (VF) is reported. The definition of VF is an increase in HIV RNA level \>0.5 log10 copies/mL compared to the baseline HIV RNA level.
Mean Change From Baseline in CD4/CD8 Cell Counts
时间窗: Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years
The mean change from baseline in CD4/CD8 counts throughout P4100 until the time of VF is reported. "Month" was defined as each 28-day period on study treatment. A fluorescent-activated cell sorter (FACS) analysis was used to quantify CD4/CD8 lymphocytes. The definition of VF is an increase in HIV RNA level \>0.5 log10 copies/mL compared to the baseline HIV RNA level.
次要结局
未报告次要终点