Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101

• ClinicalTrials.gov Identifier: NCT05143307
• Recruitment Status: Enrolling by invitation
• First Posted: December 3, 2021
• Last Update Posted: May 14, 2024
• Sponsor: Excision BioTherapeutics
• Information provided by (Responsible Party): Excision BioTherapeutics

Tracking Information

• First Submitted Date: November 22, 2021
• First Posted Date: December 3, 2021
• Last Update Posted Date: May 14, 2024
• Actual Study Start Date: July 11, 2023
• Estimated Primary Completion Date: January 2037 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 22, 2021)

Long-term safety of EBT-101 [ Time Frame: 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101
• Official Title: Long-Term Follow-Up Study of HIV-1 Infected Adults Exiting a Parent Study Where EBT-101 Was Administered
• 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.
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Long term follow up of participants who received EBT-101

Masking: None (Open Label)
Primary Purpose: Other

• Condition: HIV-1-infection

Intervention

Biological: EBT-101

Long term follow up of participants who received EBT-101

Study Arms

Experimental: Long Term Follow Up

Participants who received EBT-101 in a parent study will undergo long term follow up

Intervention: Biological: EBT-101

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: November 22, 2021): 9
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2037
• Estimated Primary Completion Date: January 2037 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Willing and able to provide written, signed informed consent
• Participants who received the investigational study intervention EBT-101 in a parent study

Exclusion Criteria:

• Participants who did not receive EBT-101 in a parent study

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05143307
• Other Study ID Numbers: EBT-101-002
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Excision BioTherapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Excision BioTherapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: William Kennedy, MD; Excision BioTherapeutics

• PRS Account: Excision BioTherapeutics
• Verification Date: May 2024