EFFECTIVENESS OF SWISH/SPIT THALIDOMIDE SOLUTION FOR ORAL ULCERS IN HIV INFECTION

这是一项开放标签研究，旨在评估 口服沙利度胺“漱口吐”溶液治疗口疮 艾滋病病毒感染者的溃疡。 患者将接受口服 沙利度胺溶液（含150 mg），每日4次，最多4 周 在治疗期间，每周对患者进行评估， 临床反应和愈合。 在前两周结束时， 观察到溃疡尺寸增大的受试者将被终止研究 并将其转介给主要提供者进行进一步护理。 2周结束时病灶大小未缩小的受试者 将选择他们是否希望继续接受研究药物， 额外2周或终止研究，并将其提交给 提供进一步护理的主要供应商。 ACTG 251研究的数据显示，大约60%的患者完成了 4周结束时的反应率。 因为已知的毒性 与系统性沙利度胺使用相关， 沙利度胺局部溶液的功效是令人感兴趣的。 在这 概念学习测验，我们将检查12名受试者的反应率 根据ACTG 251研究中观察到的应答率。 科目 将在4周结束时评估其反应程度 治疗期。 缓解程度将基于临床变化 损伤的长度和宽度。 显示l00%的患者比例 将计算4周治疗期结束时的反应。 选择的样本量为12例受试者。 如果不少于9/12例受试者 显示完全愈合，这将代表一个比例响应 (as低至）51%或（高达）100%，基于置信区间。 该缓解率与ACTG 251研究中观察到的缓解率相似。 安慰剂组在4周结束时的发生率为1/22（5%）。 甚至 如果自发愈合（没有治疗）的真实速率较高， 在本研究中，以9/12的应答率获得的置信区间 研究不会与高达 百分之五十 合格的受试者包括HIV感染的男性或手术绝育的女性 至少18岁，活检证实的阿弗他溃疡， 根据受试者病史，口腔持续时间至少2周，和/或 临床观察 将从以下患者的口咽部获得活检组织： 准注册者。 那些进入研究的人将有血液 2次获得沙利度胺水平。

This is an open-label study designed to assess the effectiveness of an oral thalidomide "swish and spit" solution on the healing of aphthous ulcers in patients with HIV infection. Patients will receive an oral thalidomide solution (containing 150 mg) four times daily for up to 4 weeks. Patients will be assessed weekly during the treatment period for clinical response and healing. At the end of the first 2 weeks, subjects noted to have an enlargement in ulcer size will be terminated from the study and referred to their primary provider for further care. Subjects who have had no reduction in lesion size at the end of 2 weeks will choose if they wish to continue to receive study drug for an additional 2 weeks or be terminated from the study and referred to their primary provider for further care. Data from the ACTG 251 study showed an approximately 60% complete response rate at the end of 4 weeks. Because of the known toxicities associated with systemic thalidomide use, the safety and potential efficacy of a topical solution of thalidomide is of interest. In this test of concept study, we will examine the response rate in 12 subjects in light of the response rate seen in the ACTG 251 study. Subjects will be assessed as to their degree of response at the end of the 4 week treatment period. Degree of response will be based upon clinical change in lesion length and width. The proportion of patients showing a l00% response at the end of the 4 week treatment period will be calculated. A sample size of 12 subjects was chosen. If no less then 9/12 subjects show complete healing, this would represent a proportion responding of (as low as) 51% or (as high as) 100%, based on confidence intervals. This response rate would be similar to that seen in the ACTG 251 study. The rate in the placebo group at the end of 4 weeks was 1/22 (5%). Even if the true rate of spontaneous healing (without treatment) is higher, the confidence intervals obtained with a response rate of 9/12 in this study would not overlap with a spontaneous response rate of as high as 50%. Eligible subjects include HIV-infected men or surgically sterile women at least 18 years of age with biopsy-confirmed aphthous ulceration of the mouth of at least 2 weeks duration by subject history and/or clinical observation. Biopsies will be obtained from the oropharynx of prospective enrollees. Those entering the study will have blood obtained on 2 occasions for thalidomide levels.