History of Changes for Study: NCT05143307

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

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	November 22, 2021	None (earliest Version on record)
2	January 24, 2022	Recruitment Status, Study Status and Contacts/Locations
3	January 27, 2022	Contacts/Locations and Study Status
4	March 4, 2022	Study Status and Contacts/Locations
5	October 17, 2022	Study Status and Contacts/Locations
6	March 9, 2023	Study Description, Study Status, Contacts/Locations, Eligibility, Arms and Interventions and Study Identification
7	August 4, 2023	Study Status, Eligibility and Contacts/Locations
8	November 3, 2023	Study Status and Contacts/Locations
9	May 13, 2024	Study Status

Comparison Format:

Study NCT05143307
Submitted Date: November 22, 2021 (v1)

Study Identification


Unique Protocol ID:	EBT-101-002
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 Study Where EBT-101 Was Administered
Secondary IDs:

Study Status


Record Verification:	November 2021
Overall Status:	Not yet recruiting
Study Start:	March 2023
Primary Completion:	January 2037 [Anticipated]
Study Completion:	April 2037 [Anticipated]

First Submitted:	November 22, 2021
First Submitted that Met QC Criteria:	November 22, 2021
First Posted:	December 3, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	November 22, 2021
Last Update Posted:	December 3, 2021 [Actual]

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).
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
Primary Purpose:	Other
Study Phase:	Phase 1
Interventional Study Model:	Single Group Assignment
	Long term follow up of participants who received EBT-101
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	9 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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:
1.	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

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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/Locations


Central Contact Person:	Study Director at ExcisionBio Telephone: 833-214-2241 Email: clinicalscience@excisionbio.com
Central Contact Backup:	Study Lead at ExcisionBio Email: clinicalscience@excisionbio.com
Study Officials:	Study Director Study Director Excision BioTherapeutics
Locations:	United States, California
	Clinical Trial Site San Francisco, California, United States, 94110 Contact:Contact: Study Coordinator
	United States, Florida
	Clinical Trial Site Orlando, Florida, United States, 32803 Contact:Contact: Study Coordinator
	United States, Missouri
	Clinical Trial Site Saint Louis, Missouri, United States, 63110 Contact:Contact: Study Coordinator
	United States, New Jersey
	Clinical Trial Site Camden, New Jersey, United States, 08103 Contact:Contact: Study Coordinator