Pharmacokinetics of BID versus QID Dosing of Sulfadiazine in HIV-infected Patient

HIV 感染患者中磺胺嘧啶 BID 与 QID 给药的药代动力学

• 批准号: 6103663
• 负责人: STEPHEN PISCITELLI
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6103663
• 关键词: AIDS therapy; HIV infections; clinical research; dosage; drug screening /evaluation; human subject; pharmacokinetics; sulfanilamides

This study is an open-label, randomized, cross-over study to compare the pharmacokinetics of sulfadiazine given on a twice daily or four times daily schedule. Ten human immunodeficiency virus-infected patients with CD4 counts below 500 will be enrolled. Patients must not have concurrent opportunistic infections and must be willing to comply with the study regimen. The study is designed to compare pharmacokinetic parameters and serum concentrations of sulfadiazine at two doses: 1000mg QID and 2000mg BID. Additionally, this study will assess the safety and tolerability of these dosage regimens. Currently, the study has received IRB approval and will begin enrolling within the next 1 to 2 months.

本研究是一项开放标签、随机、交叉研究， 研究比较磺胺嘧啶给药的药代动力学， 每日两次或每日四次。十种人 免疫缺陷病毒感染患者，CD4计数低于 将有500人报名。患者不得同时患有 机会性感染，必须愿意遵守 研究方案。该研究旨在比较药代动力学 两种剂量的磺胺嘧啶的参数和血清浓度： 1000 mg QID和2000 mg BID。此外，本研究将评估 这些剂量方案的安全性和耐受性。目前 研究已获得IRB批准，并开始 接下来的1到2个月。