NCT05143307Enrolling By Invitation1 期
Long-Term Follow-Up Study of HIV-1 Infected Adults Exiting a Parent Study Where EBT-101 Was Administered
适应症
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Long-term safety of EBT-101
研究概览
简要总结
Participants who receive EBT-101 in a parent protocol will be eligible to participate in this long-term follow-up (LTFU) study (EBT-101-002).
详细描述
Participants who receive EBT-101 in a parent protocol will be eligible to participate in this LTFU study (EBT-101-002). All participants will have follow-up visits every six months until Year 5 post EBT-101. Thereafter, all participants will have follow-up visits annually on the anniversary of EBT-101 administration until study completion at Year 15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Willing and able to provide written, signed informed consent
- •Participants who received the investigational study intervention EBT-101 in a parent study
排除标准
- •Participants who did not receive EBT-101 in a parent study
结局指标
主要结局
Long-term safety of EBT-101
时间窗: 15 years
Long-term safety of EBT-101 will be assessed based on incidence and severity of clinically significant adverse events (AEs) according to Division of AIDS (DAIDS) 2017 over 15 years
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
相似试验
已完成
1 期
Study of EBT-101 in Aviremic HIV-1 Infected Adults on Stable ARTHIV-1-infectionNCT05144386Excision BioTherapeutics6
Enrolling By Invitation
不适用
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEBRDEBNCT05708677Abeona Therapeutics, Inc22
终止
不适用
Long-term Follow-up of HIV Subjects Exposed to SB-728-T or SB-728mR-THIV-1-infectionNCT04201782Sangamo Therapeutics38
已完成
1 期
Long-term Follow-up of Participants From Studies Evaluating GSK HIV VaccineAIDSNCT01092611GlaxoSmithKline190
已完成
不适用
Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine TrialHIV-1NCT00337181U.S. Army Medical Research and Development Command114