Immune Reconstitution in HIV Disease Using Antimicrobial Treatment With Vitamin D and Phenylbutyrate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- HIV viral load
研究概览
简要总结
The aim with this study is to provide immunotherapy with vitamin D and phenylbutyrate to treatment-naive HIV infected patients to induce important antimicrobial defence mechanisms and decreased inflammation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >18 years not subjected to HAART.
- •HIV-1 infected patients with CD4 T cells counts >200 cells/ml.
- •Detectable plasma viral loads >1000 copies/ml.
排除标准
- •Patients on HAART or other antimicrobial drugs (including bactrim).
- •Antimicrobial drug treatment in the past month.
- •Patients with medical contra-indication for biopsy such as bleeding tendencies.
- •Hypercalcaemia (serum calcium > 3,0 mmol/L) identified at baseline.
- •Pregnant and breast feeding women.
- •Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides.
研究组 & 干预措施
Vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)
Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.
干预措施: vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate) (Drug)
Placebo tablets
Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
干预措施: Placebo tablets (Drug)
结局指标
主要结局
HIV viral load
时间窗: 0 (baseline) compared to 16 weeks.
Plasma HIV viral load will be used to monitor efficacy of vitamin D and phenylbutyrate treatment among treatment-naïve HIV patients at the time of diagnosis (time point 0) and at 4, 8, 16 and 24 weeks after initiation of antimicrobial treatment with vitamin D and phenylbutyrate. The primary endpoint will be assessed at 16 weeks compared to baseline (time point 0).
次要结局
- Clinical secondary endpoints(0, 4, 8, 16, 24 weeks.)
- Laboratory secondary endpoints(0, 4, 8, 16, 24 weeks.)
研究者
Susanna Brighenti
Associate professor
Karolinska Institutet