Evaluation of Kaletra Therapy Over the Long-term
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 284
- 试验地点
- 90
- 主要终点
- Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
研究概览
简要总结
Long term observation of patients under lopinavir/ritonavir containing therapy
详细描述
Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks).
These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients infected by HIV-1
- •Age greater than or equal to 18 years
排除标准
- •as described in SmPC (summary of product characteristics) at the time of prescription
研究组 & 干预措施
non-B
Patients infected with non-B subtypes of HIV-1
干预措施: Lopinavir/Ritonavir (Kaletra) (Drug)
therapy-naive
Patients who had not received prior antiretroviral drug therapy
干预措施: Lopinavir/Ritonavir (Kaletra) (Drug)
pre-treated
Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
干预措施: Lopinavir/Ritonavir (Kaletra) (Drug)
结局指标
主要结局
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
时间窗: Baseline and at any timepoint where testing is possible
Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.
次要结局
- Percentage of Patients With HIV-1 RNA <50 Copies/ml(Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks)
- Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml(Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks)
- Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml(Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks)
- Percentage of Patients With HIV-1 RNA >500 Copies/ml(Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks)
- Change in Absolute CD4 Cell Count [CD4+ Cells/µL](Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks)