Immunological Effects of an Immunomodulatory Synbiotic Intervention at Advanced HIV Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
Late diagnosed HIV-infected subjects show impaired immunological recovery resulting in a greater risk of clinical progression. Gut bacteria metabolism appears to impact immune recovery in HIV-infected subjects, and while nutritional interventions with prebiotics and probiotics seem to exert immunological effects, the clinical implications in this key population remain unknown. This is a pilot multicenter randomized placebo-controlled, double blind clinical trial in HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS. Participants will be randomized (1:1) to either the synbiotic nutritional supplement PMT25341 or placebo for 48 weeks, each in combination with first-line ART. Primary outcomes will be safety and immunological recovery. Secondary outcomes will include changes in fecal microbiota structure and plasma inflammatory markers.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected ART-naive subjects with <350 CD4 T cells/mm3 or AIDS
- •Initiating ART with any first-line regimen recommended in the Spanish GESIDA National Guidelines
排除标准
- •Age <18 years
- •Pregnancy
- •Type 1 or 2 diabetes
- •End-stage renal disease
- •Lactose intolerance
- •Use of immunomodulatory drugs
- •Neutrophil count <750cells/uL
研究组 & 干预措施
PMT25341
A mixture of prebiotics, probiotics, oligonutrients, essential aminoacids, omega-3 fatty acids
干预措施: PMT25341 (Dietary Supplement)
PLACEBO
Lactose
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Safety and tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: From baseline through week 48
Changes in CD4+ T cell counts/uL
时间窗: From baseline through week 48
Changes in CD8+ T cell counts/uL
时间窗: From baseline through week 48
Changes in CD4/CD8 ratio
时间窗: From baseline through week 48
次要结局
- Microbiota composition: alpha-diversity(From baseline through week 48)
- Changes in percentage of HLADR+/CD38+ T cells(From baseline through week 48)
- Microbiota composition: Unifrac distances(From baseline through week 48)
- Microbiota composition: Canberra distances(From baseline through week 48)
- Changes in plasma soluble CD14 levels(From baseline through week 48)
- Changes in plasma lipoteichoic acid levels(From baseline through week 48)
- Changes in plasma kynurenine/tryptophan ratio(From baseline through week 48)
- Changes in plasma hs-CRP levels(From baseline through week 48)
- Changes in plasma IFABP levels(From baseline through week 48)
研究者
Sergio Serrano-Villar
MD, PhD
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal