NCT00531206已完成不适用
Observational Non-interventional Study About Antiretroviral Combination Treatment With Aptivus in Combination With Low-dose Ritonavir in HIV Type 1 Infected Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection.
研究设计
- 研究类型
- Observational
- 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
- •Highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.
排除标准
- •Age < 18 years
- •pregnant female patients
- •Hypersensitivity to the active substance or to any of the excipients.
- •Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
- •Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.
- •Herbal preparations containing St John's wort must not be used while taking Aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir.
- •Co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and HMG-CoA reductase inhibitors (simvastatin and lovastatin). In addition, co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with drugs that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated.
研究组 & 干预措施
All participants
干预措施: Tipranavir (Drug)
All participants
干预措施: Ritonavir (Drug)
结局指标
主要结局
Adverse Events
时间窗: 52 weeks
The safety and tolerability of the observed antiretroviral therapy were based on the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported in the case report forms.
次要结局
- Discontinuations Due to an Adverse Event(52 weeks)
- Total Cholesterol Over Time(52 weeks)
- CD4+ Cell Count(Baseline and 52 weeks)
- Deaths(52 weeks)
- Number of Anti-retroviral Medications Taken in Combination With Tipranavir/Ritonavir(52 weeks)
- Body Mass Index Class (Kilograms/Square Meter)(52 weeks)
- Triglycerides Over Time(52 weeks)
- Creatinine Over Time(52 weeks)
- Adverse Events Related to Therapy With Tipranavir/Ritonavir Based on Investigator's Opinion(52 weeks)
- High Density Lipoprotein (HDL) Cholesterol Over Time(52 weeks)
- Alanine Aminotransferase (ALT) Over Time(52 weeks)
- Total Bilirubin Over Time(52 weeks)
- Aspartate Aminotransferase (ALT) Over Time(52 weeks)
- Gamma-glutamyl Transpeptidase (GGT) Over Time(52 weeks)
- Change in Viral Load(Baseline and 52 weeks)
- Subjective Well-being(52 weeks)
- Serious Adverse Events(52 weeks)
- Use of Lipid Lowering Agents During the Study(52 weeks)
- Low Density Lipoprotein (HDL) Cholesterol Over Time(52 weeks)
- Alkaline Phosphatase Over Time(52 weeks)
研究者
研究点 (1)
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