CClinicalTrials.gg
Enrolling by invitationNCT05143307Updated May 14, 2024

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

A Phase 1 interventional study of EBT-101 in HIV-1-infection, sponsored by Excision BioTherapeutics. Enrolling by invitation at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Excision BioTherapeutics · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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).

Read the 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.

02

Conditions studied

  • HIV-1-infection

Keywords

  • CRISPR
  • Gene Therapy
  • adeno-associated virus serotype 9 (AAV9)
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In context

Lead sponsor

Excision BioTherapeutics is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Participants who did not receive EBT-101 in a parent study
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    Long Term Follow Up

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

    Biological: EBT-101

Interventions

  • BiologicalEBT-101

    Long term follow up of participants who received EBT-101

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 15 years

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Study locations

3 sites
  • Quest Clinical Research
    San Francisco, California 94115, United States
  • Washington University
    Saint Louis, Missouri 63110, United States
  • Cooper Health
    Camden, New Jersey 08103, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05143307
Lead sponsor
Excision BioTherapeutics
Responsible party
Sponsor
First posted
Dec 3, 2021
Start date
Jul 11, 2023
Primary completion
Jan 2037 (estimated)
Completion
Apr 2037 (estimated)
Last update
May 14, 2024

Study contacts

William Kennedy, MD
study director · Excision BioTherapeutics

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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