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agent can lead to the achievement and maintenance of viral suppression below 20 copies/mL after Enfurvitide therapy is withdrawn.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.

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 我们建议入组25例持续低水平HIV病毒血症的HIV感染受试者，定义为血浆HIV RNA水平为50 - 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方案（见入选标准）。 抗逆转录病毒治疗方案必须是不包括恩呋维肽但含有两种或更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。 所有受试者将在其入组前方案中接受恩呋维肽90 mg每日两次SQ给药，持续12周，以确定该药物的治疗强化是否可以在恩呋维肽治疗停止后实现并维持低于20拷贝/mL的病毒抑制。 接受恩呋维肽治疗12周后仍持续低水平病毒血症的受试者将额外接受12周的药物治疗。