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临床试验/NCT00162643
NCT00162643Unknown4 期

Boosted PI VS. NNRTI Based Therapy as Initial Treatment for HIV-1 Infected Patients With Advanced Disease

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran10 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2004年12月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
发起方
入组人数
300
试验地点
10
主要终点
Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks

研究概览

简要总结

Ritonavir boosted protease inhibitor based therapy will have equivalent antiviral efficacy over 48 weeks compared to NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with CD4 counts ≤ 200/mm3.

详细描述

Current guidelines for initial therapy in HIV infection recommend 2 NRTIs plus either a ritonavir boosted protease inhibitor or a non-nucleoside reverse transcriptase inhibitor (NNRTI). Recent data suggests that the rate of response to PI based therapy may be slightly compromised if the baseline CD4 count is ≤ 200/mm3 and the plasma HIV-1-RNA ≥ 100,000 copies/mL. This may not be equally apparent if ritonavir boosted protease inhibitors are used. The effect of baseline CD4 count and HIV-1-RNA levels on the antiviral efficacy of NNRTI based regimens has been less well characterized. A significant number of patients currently initiate therapy at late stages of progression, typically with baseline CD4 count is ≤ 200/mm3. In Mexico approximately 60% of patients who initiate therapy are within this range of CD4 cell counts. Currently, the two combinations recommended as preferred are with two NRTIs and either Efavirenz or Lopinavir/ritonavir, while other combinations of PIs and ritonavir are considered alternative.

Comparison: The efficacy of ritonavir boosted protease inhibitor based therapy versus NNRTI based therapy in patients who are antiretroviral therapy naïve and initiate therapy with a CD4 count ≤ 200/mm3.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV infected individuals
  • Men or women at least 18 years old
  • CD4+ T cells ≤200/ml
  • Antiretroviral naive

排除标准

  • Suspected or documented active, untreated HIV 1 related opportunistic infection (OI) or other condition requiring acute therapy (e.g., hepatitis C virus infection)
  • Platelet count < 75,000 cells/mm
  • Hemoglobin < 9 g/dL .
  • AST and/or ALT greater than 5 times the upper limit of normal
  • Documented or suspected active tuberculosis

结局指标

主要结局

Percentage of patients who reach HIV-1-RNA ≤ 50 copies/mL at 48 weeks

次要结局

  • plasma Viral Load change from baseline
  • Clinical symptoms
  • CD4 counts
  • Safety
  • Tolerability
  • Discontinuations

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other

研究点 (10)

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