PACTG P1038: HIGH DOSE LOPINAVIR/RITONAVIR WITH OR WITHOUT SAQUINAVIR IN HIV PTS

PACTG P1038：高剂量洛匹那韦/利托那韦联合或不联合沙奎那韦治疗 HIV PTS

• 批准号: 7604296
• 负责人: Ram Yogev
• 金额: $ 0.81万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 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/7604296
• 关键词: PACTG; P1038; DOSE; LOPINAVIR; RITONAVIR

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. PACTG P1038 is a Phase I/II, open label study of high dose lopinavir/ritonavir (LPV/r) to assess the safety, tolerability, and pharmacokinetics of LPV/r with or without saquinavir (SQV) in HIV-infected children and adolescents who have at least six months of prior PI experience and are failing their current antiretroviral therapy (plasma HIV RNA greater than 5000 copies/mL). This study hypothesizes that dose intensification will not only aid in overcoming resistance but in a manner analogous to cancer will result in a greater rate of inhibition and thereby maximize the degree and durability of viral suppression. Given the limited therapeutic options available to most HIV-infected children, this is an option that should be explored. The study will seek to enroll 48 subjects = 2 years to 18 years of age. Subjects will be stratified by concurrent NNRTI treatment, and subjects will be treated for 48 weeks from the start of the initial LPV/r dose.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 PACTG P1038是一项I/II期，高剂量lopinavir/Ritonavir（LPV/R）的开放标签研究，以评估LPV/R的安全性，耐受性和药代动力学，无论是否有或没有Saquinavir（SQV）（SQV）在HIV感染的儿童和PRES六个月以前，他们在PRES的较早及其较早的pi经验中均在PRES上失败了（SQV） RNA大于5000份/毫升）。 这项研究假设剂量加强不仅有助于克服抗药性，而且以类似于癌症的方式有助于抑制率更高，从而最大程度地提高了病毒抑制的程度和耐用性。 鉴于大多数感染HIV的儿童可用的治疗选择有限，这是应该探索的选择。 该研究将寻求注册48名受试者= 2岁至18岁。 受试者将通过同时进行NNRTI治疗进行分层，并且从初始LPV/R剂量开始后将对受试者进行48周的治疗。