DELAVIRIDINE MESYLATE TREATMENT IN TRIPLE COMBINATION FOR HIV1 PATIENTS

甲磺酸地拉韦啶三联疗法治疗 HIV1 患者

• 批准号: 6290963
• 负责人: MITCHELL GOLDMAN
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6290963
• 关键词: AIDS therapy; HIV infections; antiviral agents; clinical research; clinical trials; combination chemotherapy; delavirdine; drug screening /evaluation; human subject; human therapy evaluation

This investigation is open label, with treatment assignment to one of two groups at the investigator's discretion. Subjects will be eligible for this protocol if they had previously been entered at the same site into one of the following trials. M/3331/0003, M/3331/0013, M/331/0017, M/331/0018, M/3331/0021, and M/3331/0022. Patients participating in blinded trials will not have blind broken from their previous trial before entering into this protocol. The treatment regimen of each drug for this protocol will be the number of tablets or capsules the patient was taking in their previous trial. An addition of new agent will be dosed at the recommended dosage level. For patient to enter and remain in this study, they will need to maintain a minimum dosage level of 100mg tid delavirdine, 100mg TID ZDV, 75 mg BID ddl and/or 0.0375 mg TID ddC.

这项调查是开放标签的，治疗分配给两个中的一个 由研究者自行决定分组。 受试者将有资格获得 如果它们之前已在同一站点输入此协议 以下试验之一。 M/3331/0003、M/3331/0013、M/331/0017、M/331/0018、M/3331/0021 和 M/3331/0022。 参加盲法试验的患者不会有盲法 在进入该协议之前，他们打破了之前的试验。 该方案的每种药物的治疗方案将是 患者在之前的试验中服用的片剂或胶囊。 一个 新药剂的添加将按照推荐的剂量水平进行。 为了让患者进入并留在本研究中，他们需要保持 最低剂量水平为 100mg tid 地拉韦定、100mg TID ZDV、75 mg BID ddl 和/或 0.0375 mg TID ddC。