Immune Reconstitution in Severely Immunosuppressed Antiretroviral-naive HIV-1-Infected Patients (<100 CD4+ T Cells/μL) Taking Antiretroviral Regimens Based on Dolutegravir or Ritonavir-boosted Darunavir (the Advanz-4 Trial).
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Median CD4 T cell count increase
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 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either dolutegravir, or darunavir-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
- •HIV patients > 18 years old who provide signed and dated informed consent.
- •Male and female.
- •Chronic HIV infection.
- •Antiretroviral naïve.
- •Confirmed CD4+ T cell count below 100 cells/mm3
- •HLA B5701 negative patients.
排除标准
- •Active opportunistic infections requiring parenteral treatment
- •Patients with cryptococcal meningitis treated with voriconazole
- •AIDS-defining cancers needing chemotherapy.
- •Female patients pregnant or breastfeeding.
- •Patients with documented history of allergy to sulfonamides.
- •Any contraindications to study drugs.
研究组 & 干预措施
ABC+3TC+DTG
Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen
干预措施: Dolutegravir (Drug)
ABC+3TC+DRV/r
Abacavir+lamivudine+ritonavir-boosted darunavir, QD
干预措施: Darunavir/r (Drug)
结局指标
主要结局
Median CD4 T cell count increase
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