CLINICAL TRIAL: A PHASE III COMPARATIVE STUDY OF THREE NON-NUCLEOSIDE REVERSE TR

临床试验：三种非核苷反向TR的III期比较研究

• 批准号: 8166580
• 负责人: DANIEL W NIXON
• 金额: $ 0.95万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166580
• 关键词: Adherence; Behavior; CD4 Positive T Lymphocytes; Cell Count; Clinical; Clinical Trials; Comparative Study; Computer Retrieval of Information on Scientific Projects Database; Development; Drug resistance; Ethnic Origin; Event; Evolution; Exposure to; Failure; Funding; Gender; Glucose; Grant; HIV-1; High Density Lipoprotein Cholesterol; Immunologics; Institution; Kinetics; Lipids; Metabolic; Metabolic syndrome; Myocardial Infarction; Nucleosides; Outcome; Patient Self-Report; Perception; Phase; Plasma; Prevalence; Protocols documentation; Questionnaires; RNA; Race; Regimen; Research; Research Personnel; Resistance; Resources; Risk; Source; Time; Toxic effect; Treatment Protocols; Triglycerides; United States National Institutes of Health; Viral; arm; racial difference; response; self reported behavior; transmission process

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 primary objective of this protocol is to compare the virologic efficacy and tolerability of combination regimens that include FTC/TDF plus RAL, ATV/r, or DRV/r for treatment of ARV-naive subjects. The secondary objectives include: 1.3.1 To compare the toxicity of combination regimens that include FTC/TDF plus RAL, ATV/r, or DRV/r for treatment of ARV-naive subjects. 1.3.2 To support the primary virologic endpoint in the context of treatment discontinuation and switches. 1.3.3 To compare the impact of the three treatment regimens on the evolution of drug resistance at the time of first failure and to correlate NRTI, INI, and PI genotypic resistance with kinetics of viral decay at 4 weeks after therapy initiation. 1.3.4 To compare CD4+ T-cell count responses to the three treatment regimens over time. 1.3.5 To assess the occurrence of targeted clinical events. 1.3.6 To evaluate the impact of the three treatment regimens on virologic and immunologic responses, toxicity, and tolerability by gender and race/ethnicity. 1.3.7 To examine the association of early changes and suppression in HIV-1 RNA level and long-term virologic efficacy. 1.3.8 To compare the impact of the study regimens on lipid levels, glucose, prevalence of metabolic syndrome, and Framingham scores for risk of myocardial infarction (MI). 1.3.9 To compare the effect of DRV on RTV plasma exposure to that of ATV, and to examine the relationship between RTV exposure and changes in triglycerides and non-high density lipoprotein (HDL) cholesterol in the DRV/r and ATV/r arms. 1.3.10 To examine the impact of treatment and changes in HIV-1 RNA level on perception of infectiousness, and that perception¿s impact on transmission-associated behavior over time. 1.3.11 To assess adherence to the ARV regimens using self-report questionnaires and compare differences by race/ethnicity, gender, and self-reported behaviors and to evaluate the relationship between adherence and metabolic, immunologic, and virologic outcomes, and development of HIV-resistance.

这个子项目是许多研究子项目中的一个 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。 本方案的主要目的是比较包括FTC/TDF加RAL、ATV/r或DRV/r的联合方案治疗ARV初治受试者的病毒学疗效和耐受性。 次要目标包括： 1.3.1比较包括FTC/TDF加RAL、ATV/r或DRV/r的联合方案治疗ARV初治受试者的毒性。 1.3.2在治疗中止和转换的背景下支持主要病毒学终点。 1.3.3比较三种治疗方案对首次失败时耐药性演变的影响，并将NRTI、INI和PI基因型耐药性与治疗开始后4周的病毒衰变动力学相关联。 1.3.4比较三种治疗方案随时间推移的CD4 + T细胞计数反应。 1.3.5评估目标临床事件的发生。 1.3.6按照性别和人种/种族评价三种治疗方案对病毒学和免疫学应答、毒性和耐受性的影响。 1.3.7研究HIV-1 RNA水平的早期变化和抑制与长期病毒学疗效的关系。 1.3.8比较研究方案对血脂水平、血糖、代谢综合征患病率和心肌梗死（MI）风险的Fragrance评分的影响。 1.3.9比较DRV与ATV对RTV血浆暴露量的影响，并研究RTV暴露量与甘油三酯和非高密度脂蛋白胆固醇变化之间的关系 在DRV/r和ATV/r臂中。 1.3.10检查治疗和HIV-1 RNA水平变化对感染性感知的影响，以及随着时间的推移，这种感知对传播相关行为的影响。 1.3.11使用自我报告问卷评估抗逆转录病毒治疗方案的依从性，比较人种/种族、性别和自我报告行为的差异，并评价依从性与代谢、免疫学和病毒学结局以及HIV耐药性发展之间的关系。