Multi-Center Observational Study to Assess Effectiveness and Safety of Fixed Dose Combination of Generic Product of Lopinavir/Ritonavir in HIV-1 Infected Patients After Switching From Kaletra® (Lopinavir/Ritonavir) for Administrative Reasons in the Routine Clinical Settings of Russian Federation (COPI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 239
- 试验地点
- 10
- 主要终点
- Percentage of Participants Who Meet HIV-1- RNA Viral Load >50 Copies/mL, OR CD4+ T-Cell Counts < 200 Cells/mm^3
研究概览
简要总结
This is a mixed prospective-retrospective, multi-center observational study to assess the virologic effectiveness of generic product of Lopinavir/Ritonavir (LPV/r) after switching from Kaletra in the routine clinical settings of Russian Federation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Human Immunodeficiency Virus Type-1 (HIV-1) infected patients on any dual or triple Highly Active Anti-Retroviral Therapy (HAART) with Kaletra under observation at least 48 weeks and with two consequent plasma HIV-1 RNA levels within the last 24 weeks (plasma HIV-1 RNA level <50 copies/mL) switched to a generic LPV/r as decided by the physician in the routine clinical settings within last 24 weeks from study enrollment date.
- •HIV-1 infected patients with last available CD4+ T-cell count test result > 200 cells/mm3 before switching from Kaletra.
- •Other (not LPV/r) HAART medicine components of dual or triple HIV therapy not planned to change by regular physician after switching to generic LPV/r.
- •Signed Inform Consent form by patient.
排除标准
- •Participant has contraindications for the treatment with LPV/r.
- •Legal or physical incapability of patient to sign Inform Consent form
结局指标
主要结局
Percentage of Participants Who Meet HIV-1- RNA Viral Load >50 Copies/mL, OR CD4+ T-Cell Counts < 200 Cells/mm^3
时间窗: Up to 48 Weeks
Percentage of participants who meet at least one of the following composite endpoint criteria : HIV-1- Ribonucleic Acid (RNA) viral load \>50 copies/mL, OR Cluster of differentiation 4 (CD4+) T-cell counts \< 200 cells/mm3.
Indicator of Participants Who Have a Development of New or Recurrent Opportunistic Infections or HIV-Associated Malignancies OR any SAE Associated With HIV Treatment
时间窗: From 48 Weeks Prior to Enrollment through 48 Weeks Post Enrollment
Percentage of participants who meet at least one of the following composite endpoint criteria: Development of new or recurrent opportunistic infections or HIV-associated malignancies (based on physician observation and decision), OR Any Serious Adverse Event (SAE), associated with HIV treatment.
次要结局
- Time to Failure(Up to Week 48)
- Change in HIV-1- RNA Viral Load Compared To The Last Measure On Kaletra Treatment(Up to Week 48)
- Change in CD4+ T-cell Counts Compared To The Last Measure On Kaletra Treatment(Up to Week 48)
- Percentage of Participants With Reasons For Switching From Generic LPV/r To Other Antiretroviral Therapy (ART) For HIV Therapy OR Change In The Dosing Regimen(Up to Week 48)
- Percentage of Participants Who Develop HIV Drug Resistance Of Generic LPV/r Treatment(Up to Week 48)