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

Phase 1

• Conditions: HIV-1-infection

• 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.

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-03
• Study Start: 2023-07-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2037-01
• Study Completion: 2037-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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

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