Tipranavir (PNU-140690): A Fourteen Day Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients. Report on the Post-study Option, a 46-week Treatment Period of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir

Boehringer Ingelheim0 个研究点目标入组 18 人开始时间: 1999年3月最近更新: 2014年9月25日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 18
主要终点: Number of patients with a treatment toxicity leading to study discontinuation

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To investigate the safety of a standard triple therapy regimen of delavirdine (DLV), zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with regimens of tipranavir (TPV) with and without ritonavir (RTV)

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 13 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•HIV-1 RNA ≥ 5,000 copies/mL by Roche Amplicor assay
•CD4 cell count ≥ 50 cells/mm3
•Karnofsky performance status ≥ 80
•Age ≥ 13 years
•Screening laboratory values indicative of adequate baseline organ function, Grade 0 or 1 for laboratory values based on the ACTG toxicity scale grade. Selected stable [2 months or longer] Grade 2 laboratory abnormalities were subject to sponsor's approval
•Acceptable medical history and physical examination
•Agreement to use a barrier contraceptive method for at least 1 month prior to the administration of the study medication, during the study, and for 30 days after the end of the study
•Signed informed consent
•To enter the post-study option, patients have to have completed the 14-day tipranavir phase of the trial

排除标准

•Previous treatment with any antiretroviral drugs for more than 2 weeks
•Clinically significant, active and/or acute (onset within the prior month) medical problems including opportunistic infections, such as active cryptococcosis, Pneumocystis carinii pneumonia (PCP), herpes zoster, histoplasmosis or cytomegalovirus (CMV) , or non-opportunistic diseases including, but not limited to, progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy
•History of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair compliance with the study
•Receipt of any known enzyme-inducing drugs including rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfamidine, sulfinpyrazone, or troleandomycin within 30 days prior to participation in the study
•Receipt of any investigational medication within 30 days prior to participation in the study
•Receipt of oral contraceptives within 30 days prior to participation in the study
•Pregnancy or lactation (serum ß-human chorionic gonadotropin (ß-HCG) test negative at second screen visit of the tipranavir phase of trial)
•Evidence of active substance abuse that, in the investigator's opinion, could affect study adherence
•In the investigator's judgment, inability to comply with the protocol requirements for reasons other than those specified above