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

Sponsor

Excision BioTherapeutics (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05143307

Collaborator

(none)

Enrollment

Locations

Arm

169

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Participants who receive EBT-101 in a treatment protocol will be eligible to participate in this long-term follow-up (LTFU) study (EBT-101-002).

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection	Biological: EBT-101	Phase 1

Detailed Description

Participants who receive EBT-101 in a treatment 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 Design

Study Type:

Interventional

Anticipated Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Long term follow up of participants who received EBT-101Long term follow up of participants who received EBT-101

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2037

Anticipated Study Completion Date :

Apr 1, 2037

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Long Term Follow Up Participants who received EBT-101 in a previous intervention study will undergo long term follow up	Biological: EBT-101 Long term follow up of participants who received EBT-101

Arm

Intervention/Treatment

Experimental: Long Term Follow Up

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

Biological: EBT-101

Long term follow up of participants who received EBT-101

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants who received the investigational study intervention EBT-101 in a previous intervention study
Signed Informed Consent

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trial Site	San Francisco	California	United States	94110
2	Washington University	Saint Louis	Missouri	United States	63110
3	Cooper Health	Camden	New Jersey	United States	08103

Sponsors and Collaborators

Excision BioTherapeutics

Investigators

Study Director: Study Director, Excision BioTherapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Excision BioTherapeutics

ClinicalTrials.gov Identifier:

NCT05143307

Other Study ID Numbers:

EBT-101-002

First Posted:

Dec 3, 2021

Last Update Posted:

Mar 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Excision BioTherapeutics

CRISPR

Gene Therapy

adeno-associated virus serotype 9 (AAV9)

Study Results

No Results Posted as of Mar 7, 2022