Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- faecal microbial alpha-diversity
研究概览
简要总结
Co-morbidities, including low bone mineral density, increased visceral adiposity and chronic kidney disease (CKD) are frequent in people living with HIV, and may be driven by ongoing inflammation and immune activation. Initiation of ART reduces inflammation and immune activation and is associated with changes in bone and renal biomarkers and gut microbiota. Investigators hypothesise that changes in gut microbiome when starting antiretroviral therapy correlate to changes in bone and renal biomarkers and wish to explore possible mechanisms linking these by investigating changes in markers of inflammation and immune activation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 positive
- •Age 18-64 years
- •Able to give informed consent
- •Not previously treated for chronic HIV-1 infection, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission >12 months ago
- •Due to commence antiretroviral therapy by treating clinician
排除标准
- •- Previous major intestinal surgery/inflammatory bowel conditions
- •Infective diarrhoea in the last 3 months
- •BMI<18.5
- •Currently pregnant OR planning to conceive during the study period
- •Previous use of antiretroviral therapy, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission >12 months ago
- •Use of antibiotics (except for prophylactic co-trimoxazole) within the last 2 months
结局指标
主要结局
faecal microbial alpha-diversity
时间窗: At 12 weeks
Change in faecal microbial alpha-diversity (change in mean Shannon Diversity Index score in faecal microbiota) .
次要结局
- renal glomerular biomarkers(at 12 weeks)
- bone biomarkers(at 12 weeks)
- markers of gut epithelium integrity(At 12 weeks)
- inflammatory marker(at 12 weeks)
- circulating markers of monocyte activation(at 12 weeks)