A Long Term Open Label Rollover Trial Assessing the Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV-1 Infected Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 997
- 试验地点
- 233
- 主要终点
- Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide
研究概览
简要总结
The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
研究组 & 干预措施
Group 1
Patients With Varying Degrees of Tipranavir Treatment Experience
干预措施: Tipranavir (Drug)
Group 2
Highly Tipranavir Treatment Experienced Patients
干预措施: Tipranavir (Drug)
Group 3
Tipranavir Treatment Naive Patients
干预措施: Tipranavir (Drug)
结局指标
主要结局
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
Number of Patients With Adverse Events Leading to Death
时间窗: End of Trial (>288 weeks)
NIH Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
次要结局
- Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)(Baseline to 192-240 week time interval)
- Change From Baseline in CD4 Cell Count (LOCF)(Baseline to 192-240 week time interval)