IMPACT OF THERAPEUTIC DRUG MONITORING ON VIROLOGIC RESPONSE TO A SALVAGE REGIMEN

治疗药物监测对挽救方案病毒学反应的影响

• 批准号: 7606398
• 负责人: MITCHELL J GOLDMAN
• 金额: $ 3.24万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606398
• 关键词: Blood; Caring; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Combinations; Drug Monitoring; End Point; Enrollment; Funding; Grant; HIV Infections; HIV-1; Institution; Measures; Pharmaceutical Preparations; Plasma; Protease Inhibitor; Purpose; RNA; Randomized; Research; Research Personnel; Resources; Safety; Source; Standards of Weights and Measures; Therapeutic; Treatment Protocols; United States National Institutes of Health; Upper arm; Viral Load result; Week; base; compare effectiveness; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to compare the effectiveness of using increased doses of protease inhibitor (PI) drugs to continuing standard doses in lowering viral load. The dose increases of the PI drugs will be based upon Therapeutic Drug Monitoring (TDM), which involves measuring blood levels of PIs. This study will also see if using a normalized inhibitory quotient (NIQ) helps control HIV infection better than not using NIQ and TDM drug levels and also to study the safety of increasing doses of PI drugs based on TDM. Subjects must have had at least two anti-HIV combinations of drugs, which included a PI that failed to control the HIV infection. Approximately 860 subjects will enroll into step 1, which will involve the selection of a salvage regimen. Of those, 450 subjects are expected to enter Step 2 to be randomized to one of three study arms: standard of care, standard of care with TDM, or observation. Subject participation is expected to last fourty-eight weeks. The primary study endpoint is the plasma HIV-1 RNA concentrations.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是比较增加蛋白酶抑制剂 (PI) 药物剂量与持续使用标准剂量在降低病毒载量方面的有效性。 PI 药物的剂量增加将基于治疗药物监测 (TDM)，其中涉及测量 PI 的血液水平。 这项研究还将了解使用归一化抑制商 (NIQ) 是否比不使用 NIQ 和 TDM 药物水平更有助于控制 HIV 感染，并研究基于 TDM 增加 PI 药物剂量的安全性。 受试者必须服用至少两种抗 HIV 药物组合，其中包括未能控制 HIV 感染的 PI。 大约 860 名受试者将参加第 1 步，其中涉及挽救方案的选择。 其中，预计 450 名受试者进入第 2 步，随机分配至三个研究组之一：标准护理、TDM 标准护理或观察。 受试者的参与预计将持续四十八周。 主要研究终点是血浆 HIV-1 RNA 浓度。