NCT01492803撤回不适用
A Randomized Placebo-Controlled Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Plasma LPS levels
研究概览
简要总结
This is a randomized placebo-controlled trial to examine if once daily probiotic therapy will lower serum LPS levels and immune activation among HIV-infected youth.
详细描述
This is a double masked randomized placebo-controlled trial to examine if once daily probiotic therapy will lower serum lipopolysaccharide (LPS) levels and immune activation among HIV-infected youth. The study will enroll two cohorts: (1) a cohort of subjects who are not receiving antiretroviral therapy (ART) and have absolute CD4 T-cell count greater than 350 cells/ul and quantitative HIV-1 plasma RNA (viral load) less than 50,000 copies/ml; and (2) a cohort of subjects who are receiving ART and have absolute CD4 T-cell count greater than 350 cells/ul and and quantitative HIV-1 plasma RNA (viral load) less than 400 copies/ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be considered eligible for enrollment, an individual must meet the criteria listed below.
- •Age 13 years and 0 days to 24 years and 364 days at the time of consent
- •Confirmed or suspected to have acquired HIV infection at age 10 years or older
- •HIV-1 infection as documented by any FDA-approved ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, HIV-1 DNA, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to pre-entry
- •Absolute CD4 T-cell count greater than 350 cells/ul at pre-entry
- •Cohort 1 - Not receiving ART and no exposure to ART in the 24 weeks prior to pre-entry: Quantitative HIV-1 plasma RNA (viral load) less than 50,000 copies/ml on two consecutive determinations at least 8 weeks apart in the 24 weeks prior to and including pre-entry
- •Cohort 2 - Currently receiving ART and received ART for at least the 24 weeks prior to pre-entry: Quantitative HIV-1 plasma RNA (viral load) less than 400 copies/ml on two consecutive determinations at least 8 weeks apart in the 24 weeks prior to and including pre-entry
- •Willingness to refrain from regular use of foods/supplements containing probiotics other than that supplied by the study during the course of study participation
排除标准
- •To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
- •Known hypersensitivity to probiotics
- •Active AIDS-defining condition or acute serious illness
- •Cohort 1 - Not receiving ART and no exposure to ART in the 24 weeks prior to pre-entry: Any quantitative HIV-1 plasma RNA (viral load) equal to or greater than 50,000 copies/ml during the 24 weeks prior or at pre-entry.
- •Cohort 2 - Currently receiving ART and received ART for at least the 24 weeks prior to pre-entry: Any quantitative HIV-1 plasma RNA (viral load) equal to or greater than 400 copies/ml during the 24 weeks prior or at pre-entry
- •Known history of inflammatory bowel disease or similar disorder of the GI tract
- •Current treatment with immune-modulating or immune-suppressive therapy
- •Active malignancy at pre-entry
- •Pregnancy
- •Grade 3 or higher clinical or laboratory toxicities at the time of randomization
- •Regular use of foods or supplements containing probiotics within the 2 weeks prior to randomization (see Appendix V)
- •Concurrent participation in the ATN 061, 071, 081, and/or 101 protocols
结局指标
主要结局
Plasma LPS levels
时间窗: 32 Weeks
To determine if once daily probiotic therapy decreases microbial translocation in HIV-infected youth as measured by changes in plasma LPS.
次要结局
- Plasma pro-inflammatory cytokines and macrophage activation(32 Weeks)
- Stool colonization with Lactobacillus plantarum(32 Weeks)
- Lymphocyte activation markers(32 Weeks)
- Quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count(32 Weeks)
- Stool microbial composition and genetic diversity(32 Weeks)
- Safety labs and adverse events as a measure of acceptability and tolerability of probiotics(32 Weeks)
- Food frequency and probiotics and lifestyle questionnaires(32 Weeks)
研究者
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