NCT03329560已完成1 期
Safety of Fecal Microbiota Transplant Using Oral Encapsulated PRIM-DJ2727 in HIV-infected Persons on Antiretroviral Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events related to study drug
研究概览
简要总结
The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT) is safe for people with human immunodeficiency virus (HIV) infection.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection, documented by any licensed HIV test
- •Male subjects ≥ 18 years of age
- •Identify as MSM (men who have sex with men)
- •Currently on continuous ART for ≥24 weeks prior to study entry with no change in the ART regimen within the 12 weeks prior to study
- •Ability and willingness of the participating subject to sign the informed consent form
- •No plan to change ART regimen for the study duration
- •Screening CD4+ cell count >350 cells/mm3 obtained within 45 days prior to study entry
- •HIV RNA < 20 copies/ml for ≥12 weeks (1 blip of < 500 copies/ml will be permitted)
- •Absolute neutrophil count ≥ 1000 cells/mm3
排除标准
- •Initiation of ART during acute/early HIV infection (within 6 months of HIV seroconversion)
- •Co-infection with Hepatitis B (positive HBsAg or positive HBcAb total with detectable HBV DNA levels) or Hepatitis C (positive HCV IgG with detectable HCV RNA levels)
- •Use of antibiotics 60 days prior to the study entry
- •Use of investigational therapies or vaccines 60 days prior to the study entry
- •Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
- •Cirrhosis, inflammatory bowel disease, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy
- •Diabetes mellitus
- •Any episode of acute or persistent diarrhea within 60 days prior to study entry
- •Use of any of the following medications/products for more than 3 consecutive days within the 60 days prior to study entry: Immunosuppressives, Immune modulators, Antineoplastic agents (except for topical agents for skin cancer), Probiotics and prebiotics (supplements and products).
结局指标
主要结局
Number of participants with adverse events related to study drug
时间窗: 52 weeks
Cumulative of adverse events related to study drug
时间窗: 52 weeks
Severity of adverse events related to study drug
时间窗: 52 weeks
Severity of adverse events will be based on Division of AIDS (DAIDS) grading criteria.
次要结局
- Change in the intestinal microbiome diversity(week 0, week 6)
- Change in the intestinal microbiome abundance of genera(week 0, week 6)
- Change in systemic inflammation as assessed by interleukin 6 (IL-6) levels(week 0, week 6)
- Change in gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP)(week 0, week 6)
- Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels(week 0, week 6)
研究者
Netanya Utay
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
Loading locations...
相似试验
终止
1 期
Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's DiseaseAlzheimer DiseaseNCT03998423University of Wisconsin, Madison5
尚未招募
不适用
Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC (TALENP004)Hepatocellular Carcinoma Non-resectableNCT06643533Fujian Provincial Hospital15
尚未招募
2 期
Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young AdultsFecal Microbiota TransplantationMental Health IssueIrritable Bowel Syndrome With DiarrheaNCT06297421Shenzhen Hospital of Southern Medical University88
尚未招募
不适用
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical StudyNecrotizing EnterocolitisNCT06333405Medical University of Warsaw20
招募中
1 期
Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy TreatmentDysbiosisHepatic EncephalopathyNCT06368895Fondazione Policlinico Universitario Agostino Gemelli IRCCS60