ACTG A5202 & ACTG A5224S EMTRICITABINE/TENOFOVIR OR ABACAVIR/LAMIVUDINE FOR HIV

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。A5202是一项iii期、随机、四组研究，比较开放标签利托那韦（RTV）增强阿扎那韦（ATV）与依非韦伦（EFV）联合每日恩曲他滨(FTC)/替诺福韦（TDF）或阿巴卡韦(ABC)/拉米夫定（3TC）的疗效、安全性和耐受性，以及部分盲法ABC/3TC与FTC/TDF联合RTV增强ATV或EFV作为HIV-1感染的初始治疗。三个主要目标是：(1)比较病毒学失败方案之间的病毒学疗效，病毒学失败定义为16周后和24周前确认血浆HIV-1 RNA水平为>1000拷贝/ml或24周后或24周后确认血浆HIV-1 RNA水平为>200拷贝/ml。(2)比较两种方案的安全性，安全性定义为首次出现3级或4级体征、症状或实验室异常的时间，且至少比基线高一个级别。(3)比较不同治疗方案之间的耐受性，耐受性定义为在初始治疗方案中更换一种或多种药物的时间。a5224将探讨HIV-1感染受试者在接受FTC/TDF或ABC/3TC联合EFV或ATV联合RTV治疗时的代谢变化。a5224的主要目的是评估在开始含有ABC/3TC或TFC/TDF的抗逆转录病毒治疗方案（B/D或A/C组）后治疗组内外周脂肪变化（四肢脂肪）的变化，并比较开始含有ABC/3TC的抗逆转录病毒治疗方案与含有FTC/TDF的抗逆转录病毒治疗方案对骨密度的影响，通过腰椎和髋关节双能x线吸收仪评估（B/D组与A/C组）。假设是：(1)Af5202中FTC/TDF和ABC/3TC组与相对较少的肢体脂肪损失相关；(2)与其他NRTI手臂相比，含有tdf的手臂会导致更高的骨质流失率。

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. A5202 is a phase IIIB, randomized, four-arm study, comparing the efficacy, safety and tolerability of open-label ritonavir (RTV)-enhanced atazanavir (ATV) to efavirenz (EFV), in combination with either daily emtricitabine (FTC)/tenofovir (TDF) or abacavir (ABC)/lamivudine (3TC) and of partially blinded ABC/3TC compared to FTC/TDF in combination with either RTV-enhanced ATV or EFV as initial therapy for HIV-1 infection. The three primary objectives are: (1) To compare virologic efficacy between regimens with virologic failure defined as the time to confirmed plasma HIV-1 RNA level >1000 copies/ml or after 16 weeks and before 24 weeks or >200 copies/mL at or after week 24. (2) To compare the safety between regimens with safety defined as the time to first development of Grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline. (3) To compare the tolerability between regimens with tolerability defined as the time to change in one or more drugs in the initial treatment regimen. A5224s will explore the metablic changes in HIV-1 infected subjects receiving either FTC/TDF or ABC/3TC with either EFV or ATV with RTV. The primary objects of A5224s are to assess changes within treatment arms in peripheral fat changes (limb fat) after the initiation of an ARV regimen containing ABC/3TC or TFC/TDF (Arms B/D or A/C) and to compare the effects of initiation of an ARV regimen containing ABC/3TC with those of a regimen containing FTC/TDF on bone mineral density, as assessed by lumbar spine and hip dual energy x-ray absorptiometry (Arms B/D versus A/C). The hypotheses are: (1) FTC/TDF and ABC/3TC arms in Af5202 will be associated with relatively little loss of limb fat; and (2) TDF-containing arms will lead to higher rates of bone loss when compared to the other NRTI arms.