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

ACTG A5202

• 批准号: 7604863
• 负责人: JEFFERY L MEIER
• 金额: $ 0.48万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604863
• 关键词: AIDS clinical trial group; Atazanavir; Blinded; Bone Density; Computer Retrieval of Information on Scientific Projects Database; Daily; Development; Failure; Fatty acid glycerol esters; Funding; Grant; HIV; HIV-1; Hip region structure; Infection; Institution; Label; Laboratories; Lamivudine; Lead; Limb structure; Peripheral; Pharmaceutical Preparations; Phase; Plasma; RNA; Randomized; Rate; Research; Research Personnel; Resources; Ritonavir; Safety; Signs and Symptoms; Source; Tenofovir; Time; Treatment Protocols; United States National Institutes of Health; Upper arm; Vertebral column; Week; abacavir; bone loss; efavirenz; emtricitabine

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.

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。 A5202是一项IIIB期，随机的四臂研究，将开放标签的利托纳维尔（RTV）增强的Atazanavir（ATV）与Efavirenz（EFV）的功效，安全性和耐受性进行比较，并与每天的Emtricabine（FTC）/tenofovir（ftc）/tenofovir（tddf）（tdf）（tdf）（tdf）（tdf）（tdf）（efv）结合使用（EFV）（EFV）与FTC/TDF与RTV增强的ATV或EFV相比，部分盲目的ABC/3TC作为HIV-1感染的初始疗法。 这三个主要目标是：（1）比较病毒学衰竭方案之间的病毒学功效，定义为确认的等离子HIV-1 RNA水平> 1000份/ml或16周后，或者在24周之前，或在24周或在24周或之后进行200份或> 200份/mL之前或> 24周之后的安全性，以比较既定的阶段或签名的安全性，或者是签名或4签名，或者在3号或4号签名中，或4签名，或者在3号或4号签名的范围或4签名。比基线时高1年级。 （3）将方案之间的耐受性与最初治疗方案中一种或多种药物变化的耐受性进行比较。 A5224S将探索带有EFV或带有RTV的ATV接收FTC/TDF或ABC/3TC的HIV-1感染受试者的Metablic变化。 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腰椎和臀部双能X射线吸收仪（臂B/D与A/C）。 假设是：（1）AF5202中的FTC/TDF和ABC/3TC臂将与肢体脂肪的损失相对较小； （2）与其他NRTI臂相比，含TDF的臂将导致骨质流失率更高。