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临床试验/NCT00491556
NCT00491556已完成不适用

Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r) in Adolescents With CD4 + T Cells > 350 Cells/mm3 Initiating HAART

University of North Carolina, Chapel Hill45 个研究点 分布在 2 个国家目标入组 102 人开始时间: 2007年10月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
45
主要终点
Difference in CD4+ T Cell Percentage Between Week 0 and Week 48
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then de-intensification management strategy in adolescents with mild immunosuppression and compare changes in CD4% from baseline to week 48 and then during de-intensification.

详细描述

This is a randomized, proof of concept study of youth 18- 24 years of age with confirmed HIV after age 9 with CD4+ T cells above 350 cells/mm3 who are randomized 3:1 to begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for two years. Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 24 Years（Adult）
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Difference in CD4+ T Cell Percentage Between Week 0 and Week 48

时间窗: Week 0 and Week 48

Difference in CD4+ T Cell Percentage Between Week 48 and Week 152

时间窗: 152 Weeks

次要结局

  • Difference in CD8+ TEMRo Count Between Week 0 and Week 48(48 weeks)
  • Difference in CD8+ TEMRa Count Between Week 0 and Week 48(48 weeks)
  • Difference in CD4+ TEMRo Count Between Week 48 and Week 152(152 weeks)
  • Difference in CD4+ TEMRa Count Between Week 0 and Week 48(48 weeks)
  • Difference in CD8+ TEMRo Count Between Week 48 and Week 152(152 weeks)
  • Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152(152 weeks)
  • Difference in CD8+ TCM Count Between Week 0 and Week 48(48 weeks)
  • Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48(48 weeks)
  • Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152(152 weeks)
  • Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48(48 weeks)
  • Difference in CD4+ T Cell Count Between Week 48 and Week 152(152 weeks)
  • Difference in CD4+ TEMRa Count Between Week 48 and Week 152(152 weeks)
  • Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48(48 weeks)
  • Difference in CD8+ TEMRa Count Between Week 48 and Week 152(152 weeks)
  • Difference in CD4+ T Cell Count Between Week 0 and Week 48(48 weeks)
  • Difference in CD4+ TCM Count Between Week 48 and Week 152(152 weeks)
  • Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8+ TCM Count Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48(48 weeks)
  • Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152(152 weeks)
  • Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48(48 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (45)

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