Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101
- Conditions
- HIV-1-infection
- Interventions
- Biological: EBT-101
- Registration Number
- NCT05143307
- Lead Sponsor
- Excision BioTherapeutics
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Male
- Target Recruitment
- 9
- Willing and able to provide written, signed informed consent
- Participants who received the investigational study intervention EBT-101 in a parent study
• Participants who did not receive EBT-101 in a parent study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Long Term Follow Up EBT-101 Participants who received EBT-101 in a parent study will undergo long term follow up
- Primary Outcome Measures
Name Time Method Long-term safety of EBT-101 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Quest Clinical Research
🇺🇸San Francisco, California, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Cooper Health
🇺🇸Camden, New Jersey, United States