Retinoic Acid Effect on Cell Surface Molecules in Vivo
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
This study will follow a group of healthy male participants for about 18 weeks to see the effect of taking Acitretin on their immune cells
详细描述
Retinoids have been shown in in vitro and ex vivo models to have the ability to reverse latency reactivating the HIV reservoir and the potential for selective eradication of HIV-harbouring cells. We feel that acitretin shows significant potential as a potential adjuvant to current ART regimens, however, there is a lack of data to demonstrate that treatment with acitretin at normal are able to induce molecular and transcription changes consistent with the above activities. In order to provide a scientific basis for retinoid therapy in HIV infection, a Phase I trial of acitretin in human subjects is proposed.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male gender
- •Age 18 - 65
- •Able to provide informed consent
- •Willingness to participate in study treatment and follow-up
- •Willingness for serial phlebotomy and storage and future viro-immunological assays
排除标准
- •Female gender
- •Participants with a known hypersensitivity/allergy to the acitretin.
- •Participants who are actively participating in an experimental therapy study or who have received experimental therapy within the last 1 year.
- •Participants who are a poor medical risk because of other systemic diseases or active uncontrolled infections including HIV, Hepatitis B or C, and tuberculosis
- •Participants with impaired glucose tolerance including prediabetes or diabetes mellitus, dyslipidemia, or liver dysfunction
- •Previous or current history of mood disorder, psychosis, or suicidality
- •Participants currently receiving ongoing treatment with methotrexate, tetracyclines, or other retinoids
研究组 & 干预措施
Acitretin treatment
干预措施: Acitretin (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: up to 5 months
Safety of Acitretin use in healthy volunteers will be assessed using safety labs and C-SSRS
次要结局
- Change in α4β7 expression on peripherally circulating CD4 T cells(Serial phlebotomy measured over 5 months)
- Area Under the Curve [AUC]).(Trough concentrations measured serially over 2 months of active treatment)
- Maximum Plasma Concentration [Cmax](Trough concentrations measured serially over 2 months of active treatment)
- Change in RIG-1 expression, p300 expression, mTOR expression(Serial phlebotomy measured over 5 months)