CLINICAL TRIAL: ENFURVITIDE (T-20) INTENSIFICATION FOR LOW LEVEL VIREMIA (THE LO

临床试验：恩夫维肽 (T-20) 强化治疗低水平病毒血症 (LO

• 批准号: 7716849
• 负责人: DAVID A WOHL
• 金额: $ 1.46万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-02 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716849
• 关键词: Achievement; Anti-Retroviral Agents; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Enrollment; Funding; Grant; HIV; Institution; Lead; Maintenance; Pharmaceutical Preparations; Plasma; Protease Inhibitor; RNA; Research; Research Personnel; Resources; Ritonavir; Source; T-20; Treatment Protocols; United States National Institutes of Health; Viral; Viremia; Week; day; inclusion criteria; non-nucleoside reverse transcriptase inhibitors

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. We propose to enroll 25 HIV-infected subjects with persistent low level HIV viremia defines as a plasma HIV RNA level of 50 to 1000 copies/mL on a minimum of three occasions separated by at least 12 weeks while on a stable potent antiretroviral regimen (see inclusion criteria). The antiretroviral regimen must be a combination that does not include Enfurvitide but contains two or more active agents of which one must be a non-nucleoside reverse transcriptase inhibitor or a ritonavir-boosted protease inhibitor. All subjects will receive the addition of Enfurvitide administered 90 mg twice a day SQ for 12 weeks to their pre-entry regimen to determine if treatment intensification with this agent can lead to the achievement and maintenance of viral suppression below 20 copies/mL after Enfurvitide therapy is withdrawn. Subjects with continued low level viremia despite 12 weeks of enfurvitide will be offered an additional 12 weeks of the medication.

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。 我们建议招募 25 名持续低水平 HIV 病毒血症的 HIV 感染受试者，定义为血浆 HIV RNA 水平为 50 至 1000 拷贝/mL，至少 3 次，间隔至少 12 周，同时接受稳定的强效抗逆转录病毒治疗（参见纳入标准）。 抗逆转录病毒治疗方案必须是不包括恩夫维肽但包含两种或多种活性药物的组合，其中一种必须是非核苷逆转录酶抑制剂或利托那韦增强的蛋白酶抑制剂。 所有受试者将在入组前的治疗方案中添加恩夫维肽，每次 90 毫克，每天两次 SQ，持续 12 周，以确定恩夫维肽治疗后强化治疗是否可以实现并维持低于 20 拷贝/mL 的病毒抑制被撤回。 尽管使用恩夫维肽 12 周，但仍出现低水平病毒血症的受试者将再接受 12 周的药物治疗。