NCT00205231已完成不适用
A Pilot Study to Examine the Feasibility and Effect on Tumor Necrosis Factor (TNF) Inhibition on HIV Disease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- changes in CD4 counts
研究概览
简要总结
This pilot study will investigate the safety and effect of etanercept in HIV infection by studying HIV replication and immune function (as measured by CD4 counts) in individuals with HIV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •Adults greater than 18 years of age with documented HIV infection
- •Highly active antiretroviral therapy (HAART) regimens as defined by the Department of Health and Human Services guidelines; stable regimens for 12 weeks.
- •CD4 greater than 200 at time of study enrollment
- •Stable monitoring labs (hematology survey with differential, ALT, creatinine)
- •Absolute neutrophil count within normal limits
排除标准
- •AIDS defining illness within the last 6 months
- •Acute bacterial, viral, or fungal infection within the last 1 month, or history of recurring infections
- •Women who are pregnant or nursing
- •Hypersensitivity to etanercept
- •Previous use of etanercept
- •Acute malignancy in the last 5 years excluding in situ cervical cancer (CA) and common skin cancers (non melanoma)
- •History of active or latent tuberculosis
- •History of demyelinating nerve disease
- •History of seizure disorder
- •Latex allergy
- •Subject has any of the following laboratory values within 30 days of baseline:
- •hemoglobin concentration < 10.0 g/dl for men and < 9.0 g/dl for women
- •platelet count < 75,000/mm3
- •AST or ALT > 5x upper limit of normal (ULN)
- •serum creatinine > 2.5x ULN
- •serum pancreatic amylase > 1.5 ULN
- •Subject requiring treatment with immunomodulating agents, such as systemic corticosteroids, interleukins, vaccines, or interferon
- •Subjects who chronically use any over-the-counter (OTC) or prescription medication (except vitamins) must not change the regimen or switch their medication within 3 days of drug administration and until discharged from the study.
结局指标
主要结局
changes in CD4 counts
changes in HIV-RNA levels
次要结局
- degree of TNF inhibition by measuring TNF levels
- development of infections
- changes in hematologic and biochemical laboratory tests
研究者
研究点 (2)
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