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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05143307
Recruitment Status : Enrolling by invitation
First Posted : December 3, 2021
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
Excision BioTherapeutics

Study Description
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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).

Condition or disease Intervention/treatment Phase
HIV-1-infection Biological: EBT-101 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Long 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 Parent Study Where EBT-101 Was Administered
Actual Study Start Date : July 11, 2023
Estimated Primary Completion Date : January 2037
Estimated Study Completion Date : April 2037

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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Arm Intervention/treatment
Experimental: Long Term Follow Up
Participants who received EBT-101 in a parent study will undergo long term follow up
 Biological: EBT-101
Long term follow up of participants who received EBT-101


Outcome Measures
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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 Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05143307


Locations
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United States, California
Quest Clinical Research
San Francisco, California, United States, 94115
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Health
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
Excision BioTherapeutics
Investigators
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Study Director: William Kennedy, MD Excision BioTherapeutics
More Information
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Responsible Party: Excision BioTherapeutics
ClinicalTrials.gov Identifier: NCT05143307    
Other Study ID Numbers: EBT-101-002
First Posted: December 3, 2021    Key Record Dates
Last Update Posted: November 7, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Excision BioTherapeutics:
CRISPR
Gene Therapy
adeno-associated virus serotype 9 (AAV9)