An Open Label Trial of TMC114/Rtv in HIV-1 Infected Subjects Who Were Randomized in the Trials TMC114-C201, TMC114-C207 or in Sponsor Selected Phase I Trials
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination
研究概览
简要总结
The purpose of this study was primarily to assess the long-term safety and tolerability of TMC114/rtv in addition to an individually optimized background antiretroviral therapy in HIV-1 infected participants. In addition, antiviral activity and immunological effect were also evaluated.
详细描述
This was a phase II, open label, multicenter trial of an investigational protease inhibitor TMC114 in the presence of ritonavir (rtv) in HIV-1 infected participants who were randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected phase I trials and who might derive benefit from TMC114 therapy, as judged by the investigator.
The trial consisted of a screening period of a maximum of 4 weeks, a 96-week treatment period and a 4-week follow-up period. The maximal trial duration for each participant was104 weeks. During the treatment period, all participants were receiving TMC114 in combination with RTV, orally, as 600/100 mg dose twice daily, in addition to an individually optimized background regimen of antiretroviral (ARV) therapy, selected by the investigator at a baseline of the study.
Sponsor provided a follow-up treatment with TMC114 for all participants who continued to benefit from treatment with TMC114/RTV until it became commercially available for the participant. Participants, who completed the 96 weeks of treatment period with TMC114, had the opportunity to roll over to the extension of this trial, if TMC114 was not locally commercially available.
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
- 未提供
排除标准
- •A disallowed concomitant therapy
- •Current or past history of active alcohol and/or drug use
- •Pregnant or breast-feeding females
- •Any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction; pancreatitis; acute viral infections)
- •Clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis
- •Clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication
- •Laboratory abnormalities at screening (criteria variable according to the test)
研究组 & 干预措施
TMC114 + rtv
Every participant recieves 2 tablets of TMC114, 300 mg, combined with one tablet of rtv (ritonavir), 100mg, orally twice daily, every 12 hours
干预措施: TMC114 (Drug)
TMC114 + rtv
Every participant recieves 2 tablets of TMC114, 300 mg, combined with one tablet of rtv (ritonavir), 100mg, orally twice daily, every 12 hours
干预措施: rtv (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination
时间窗: Baseline, up to the end of follow-up period (approximatelly 100 weeks)
次要结局
- Change in CD4 cells absolute count(Week 48, Week 96)
- Number of patients with HIV-1 plasma viral load level <50 copies/mL (TLOVR, non-VF censored)(Week 48, Week 96)