EUCTR2011-005973-21-IT进行中（未招募）不适用
A prospective, randomized, open-label trial of two abacavir/lamivudine based regimen (ABC/3TC + darunavir/ritonavir or ABC/3TC + raltegravir) in late presenter naïve patients (with CD4 count <200 cells/µL - advanced HIV disease) - RTLP
AZIENDA OSPEDALIERA POLICLINICO DI MODENA0 个研究点开始时间: 2012年3月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Males or females aged 18-64 years who are HIV-1 antibody seropositive, with a CD4 count <200 cells/uL. 2. All patients should be antiretroviral-naive 3. All patients should be HLA B57 or HLA B5701 negative 4. Patients must have an HIV RNA level <500,000 copies/mL 5. Patients with an active opportunistic infection could be enrolled as long as this was diagnosed more than 2 weeks prior to screening. 6. Patients must meet the following laboratory criteria. Neutrophil count ? 1,000 cells/mm3 Haemoglobin > 9.0 grams/dl (men and women) Platelet count = 75,000 cells/mm3 Alkaline phosphatase < 3.0 the upper limit of normal ALT and AST < 3.9 times the upper limit of normal Total bilirubin < 1.5 times the upper limit of normal. 7. Female patients of childbearing potential must be willing to use a reliable form of contraception, which will include a medically approved form of barrier contraception. 8. Patients must be able to provide written consent to comply with study requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 350
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with genotypic mutations for any of the study drugs. 2. Patients with an opportunistic infection diagnosed in the 2 weeks prior to screening. 3. Female patients who are pregnant or breastfeeding. 4. Patients who are receiving any investigational drug or anti-neoplastic radiotherapy/chemotherapy other than local skin radiotherapy within 12 weeks before randomization. 5. Patients with a current history of intravenous drug abuse, alcohol or substance abuse.
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