NCT02640625已完成1 期
Adjuvant Mucosal Therapy in HIV-infected Men With Insufficient Response to Antiretroviral Therapy
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse Effects
研究概览
简要总结
The primary objective of this study is to assess the safety of probiotics in cART-treated immunologic non-responder (INR) patients with chronic HIV infection.
The secondary objectives are to i) explore the biological effects of probiotics in combined antiretroviral therapy(cART)-treated INR patient with chronic HIV infection, and ii) investigate differences between cART-treated HIV-infected INR and non-INR patients with regards to gut microbial composition and mucosal barrier function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •HIV seropositive >4 years.
- •Continuous combined antiretroviral treatment (cART) >4 years.
- •Plasma HIV RNA <50 copies/mL >3,5 years.
- •Cluster of differentiation(CD)4+ T cell count <400 cells/µL (OR >600 cells/µl) >3.5 years.
- •Caucasian
- •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
排除标准
- •Plasma hepatitis C (HCV) RNA positive.
- •Serum hepatitis B surface antigen (HBsAg) positive.
- •Comorbidity of inflammatory bowel disease, coeliac disease or malnutrition.
- •Concomitant use of non-steroid anti-inflammatory drugs (NSAID), corticosteroids, disease-modifying antirheumatic drugs, or other anti-inflammatory pharmaceutical substances.
- •Concomitant use of antithrombotic pharmaceutical substances
- •Regular (weekly) use of any probiotic substance within 3 months prior to inclusion.
- •Use of antibiotics within 3 months prior to inclusion.
- •Deranged liver function (serum albumin <25 g/L or Child-Pugh ≥10)
- •Renal failure (estimated glomerular filtration rate (eGFR) <30 ml/min)
- •Heart failure (NYHA class II-IV)
- •Intolerance to milk or phenylalanine
- •Any reason why, in the opinion of the investigator, the patient should not participate
结局指标
主要结局
Adverse Effects
时间窗: 10 weeks
Number of Participants who Experienced Adverse Effects
Delta HIV Viral Load
时间窗: 8 weeks
Unit og Measure: copies/mL
Delta Blood CD4 Count
时间窗: 8 weeks
Unit of Measure: cells/microL
次要结局
- Alterations in Epithelial Gene Expression(8 weeks)
- Alterations in Systemic T Cell Intracellular Signaling(8 weeks)
- Alterations in Lamina Propria T Cell Subsets(8 weeks)
- Alterations in Systemic Markers of Immune Activation(8 weeks)
- Alteration in Gut Microbiota Composition(8 weeks)
研究者
Dag Henrik Reikvam
MD PhD
Oslo University Hospital
研究点 (2)
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