Long-Term Follow-Up Study of HIV-1 Infected Adults Who Re... | NCT05143307

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

NCT05143307

Sponsor

Excision BioTherapeutics

Status

Enrolling by invitation

Last Update Posted

May 14, 2024Actual

Enrollment

9Estimated

Phase

Phase 1

Conditions

HIV-1-infection

Interventions

EBT-101

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2023Actual

Primary Completion Date

Jan 2037Estimated

Completion Date

Apr 2037Estimated

First Submitted Date

Nov 22, 2021

First Submission Date that Met QC Criteria

Nov 22, 2021

First Posted Date

Dec 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2024

Last Update Posted Date

May 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Long Term Follow Up	Experimental	Participants who received EBT-101 in a parent study will undergo long term follow up	Biological: EBT-101

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EBT-101	Biological	Long term follow up of participants who received EBT-101	Long Term Follow Up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Kennedy, MD	Excision BioTherapeutics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Quest Clinical Research		San Francisco	California	94115	United States
Washington University

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided