NCT00275444已完成2 期
Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 73
- 主要终点
- Virologic response after 2 weeks of functional monotherapy
研究概览
简要总结
A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Signed informed consent prior to trial participation.
- •Human immunodeficiency virus 1 (HIV-1) infected males or females > 18 years of age.
- •At least 3 months experience taking Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease inhibitors (PIs).
- •Current PI-based Antiretroviral (ARV) medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen.
- •HIV-1 viral load ≥1000 copies/mL at screening.
- •Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M.
- •Availability of 2 or more non-PI ARV medications by genotypic resistance testing, i.e. 2 drugs tested as "no evidence of resistance" or "possible resistance".
- •Acceptable screening laboratory values that indicate adequate baseline organ function.
- •Laboratory values are considered to be acceptable if severity is no higher than Grade 3 Gamma glutamyl transferase (GGT), Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the "Division of Acquired Immune Deficiency Syndrome" of National Institute of Health, USA - DAIDS - Grading Scale. All laboratory values outside these limits are subject to approval by Boehringer Ingelheim (BI).
- •Further inclusion criteria apply.
排除标准
- •ARV medication naïve.
- •Only one or no available ARV medications as determined by genotypic resistance testing.
- •Female subjects who:
- •have a positive serum pregnancy test at screening or during the study;
- •are breast feeding;
- •are planning to become pregnant;
- •are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam).
- •Any active opportunistic infection within 60 days before study entry.
- •Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) > Grade
- •Prior tipranavir use.
- •Use of investigational medications within 30 days before study entry or during the trial.Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable.
- •Use of concomitant drugs which may significantly reduce plasma levels of the study medications.
- •Further exclusion criteria apply.
结局指标
主要结局
Virologic response after 2 weeks of functional monotherapy
时间窗: At week 2
次要结局
- Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures.(Up to 24 weeks)
研究者
研究点 (73)
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