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NCT05143307 Clinical Trial

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

HIV-1-infection Clinical Trial

Official title:
Long-Term Follow-Up Study of HIV-1 Infected Adults Exiting a Parent Study Where EBT-101 Was Administered

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05143307
Other study ID # EBT-101-002
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date July 11, 2023
Est. completion date April 2037

Study information
Verified date May 2024
Source Excision BioTherapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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 information / eligibility
Status Enrolling by invitation
Enrollment 9
Est. completion date April 2037
Est. primary completion date January 2037
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• EBT-101
Long term follow up of participants who received EBT-101

Locations
Country Name City State
United States Cooper Health Camden New Jersey
United States Washington University Saint Louis Missouri
United States Quest Clinical Research San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Excision BioTherapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term safety of EBT-101 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 15 years
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