EUCTR2005-002114-38-ES进行中（未招募）1 期
Ensayo randomizado para determinar el tratamiento óptimo de pacientes con infección por VIH en quienes la terapia con TARGA de primera y segunda línea ha fracasado - Options in management with antiretrovirals
Medical Research Council Clinical Trials Unit0 个研究点目标入组 504 人开始时间: 2005年11月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 504
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Ability to provide Informed Consent
- •2)Age of 18 years or more
- •3)Serologic or virologic diagnosis of HIV infection
- •4)Had failure* of at least two different multi-drug regimens that included drugs of all 3 classes that the patient can tolerate
- •laboratory evidence of resistance** to drugs in each of the 3 classes
- •5)Had at least 3 months of current ART and is still on treatment (unless a new failure*, defined as (c) below)
- •6)Two most recent results (which can include screening) on current ART of :
- •CD4+ T-cell count £ 300 cells/mm3 or £ 15%,
- •and plasma viral load ³ 5,000 copies/ml (by Roche Amplicor, v1.0) or
- •³ 2,500 copies/ml (by bDNA: Bayer v3.0/Chiron v3.0, or PCR: Roche Amplicor Monitor/COBAS v1.5)
- •*Failure (since availability of viral load tests) is defined as:
- •(a)failure to suppress plasma viral load after 24 weeks of therapy, or
- •(b)a rebound of at least 0.5 log10 in plasma viral load from nadir, or
- •(c)less than 0.5 log10 drop by (bDNA: Bayer v 3.0/Chiron v3.0, or PCR: Roche AmplicorMonitor/COBAS v1.5) or less than 1.0 log10 drop (Roche Amplicor v1.0), in plasma viral load after at least 4 weeks continuous treatment with a current new multi-drug regimen
- •(in the therapeutic era before viral load testing was available) failure is defined as:
- •CD4 decline >50% from peak treatment response, or below pretreatment level, or clinical progression of HIV disease.
- •** Resistance (this could be from screening susceptibility test) is defined either as:
- •(a)genotypic (defined as the presence of primary mutations associated with resistance to at least 2 drugs in each class), OR
- •(b)phenotypic evidence of 3-class resistance
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •b. Exclusion Criteria:
- •1)Pregnancy, breast-feeding or planned pregnancy
- •2)Likelihood of poor protocol follow-up or if Mega-ART is not feasible (due to significant intolerance of many ART drugs)
- •3)Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening
- •4)Likelihood of early death due to non HIV-disease
研究者
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