Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned
研究概览
简要总结
There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.
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
- 否
入选标准
- •Chronic HIV-1 infection
- •Age 18 or more
- •Antiretroviral-naive
- •Baseline CD4+ count <100 cels/mcL.
- •No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M)
- •Written informed consent
排除标准
- •Hypersensibility to study drugs.
- •Pregnancy or breastfeeding
- •Active OI requiring admission
- •Active lymphoma or malignancy (Kaposi sarcoma included)
- •Cl creatinine below 30 ml/min.
- •Liver failure
- •Treatment with nephrotoxic drugs, immunomodulators, interleukine-2, systemic steroids or investigational products.
研究组 & 干预措施
1
tenofovir plus emtricitabine plus efavirenz
干预措施: tenofovir + emtricitabine + efavirenz (Drug)
2
tenofovir plus emtricitabine plus lopinavir-ritonavir
干预措施: tenofovir + emtricitabine + lopinavir-ritonavir (Drug)
3
tenofovir plus emtricitabine plus atazanavir-ritonavir
干预措施: tenofovir + emtricitabine + atazanavir-ritonavir (Drug)
结局指标
主要结局
Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned
时间窗: 48 weeks
次要结局
未报告次要终点
研究者
Juan A. Arnaiz
MD, PhD
Hospital Clinic of Barcelona