课题基金 / 基金详情

OPEN LABEL TREATMENT OF HIV INFECTED SUBJECT WITH TIMUNOX

OPEN LABEL TREATMENT OF HIV INFECTED SUBJECT WITH TIMUNOX
使用 TIMUNOX 对 HIV 感染者进行开放标签治疗
批准号:
6290949
负责人:
Kenneth H. Fife
金额:
$1.7万
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-12-01 至 1999-11-30

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中文摘要
翻译
这将是一项开放标签治疗研究。 完成后 正在进行的热喷丁美国临床2期或3期治疗方案 研究中,受试者将有机会入组本开放式- 标签研究,并将接受皮下注射胸腺五肽,50 每周3次,隔日1次。 受试者目前 将允许入组正在进行的开放标签方案(07.32.008-80) 加入这项研究 受试者将保持其先前的 分配的研究编号,并将继续自我给药, 注射剂 停止胸腺五肽治疗的受试者 超过1个月将不允许重新开始胸腺五肽,除非 研究者和受试者认为, 帐号吧. 如果决定重新开始使用胸腺五肽,请填写 必须由申办者向申办者提供基本原理文件, 研究者在重新开始治疗前。
英文摘要
This will be an open-label treatment study. Upon completion of the treatment regimen in an ongoing thermopentin U.S. clinical Phase 2 or 3 study, subjects will be offered the opportunity to enroll in this open- label study and will receive subcutaneous injections of thymopentin, 50 mg.1.0 mL, three times a week, every other day. Subjects currently enrolled in the ongoing open-label protocol (07.32.008-80) will be allowed to roll over into this study. Subjects will maintain their previously assigned study number and will continue to self-administer theri injections. Subjects whodiscontinue treatment with thymopentin for more than 1 month will not be allowed to restart thymopentin unless the investigator and the subject feel it is in the subjects best interest to do so. If a decision to restart thymopentin is make, complete written documentation of the rationale must be provided to the Sponsor by the Investigator prior to restarting treatment.
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