HIV-1-infectionPhase 1NCT05143307
Long-Term Follow-Up Study of HIV-1 Infected Adults Who Received EBT-101
A Phase 1 study testing EBT-101 in people with HIV-1-infection, run by Excision BioTherapeutics at 3 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- EBT-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jul 2023to Apr 2037
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written, signed informed consent
- Participants who received the investigational study intervention EBT-101 in a parent study
Who cannot join
- Participants who did not receive EBT-101 in a parent study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Cooper Health
Camden, New Jersey, 08103
Quest Clinical Research
San Francisco, California, 94115
Washington University
St Louis, Missouri, 63110
About this study
Official title: Long-Term Follow-Up Study of HIV-1 Infected Adults Exiting a Parent Study Where EBT-101 Was Administered
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.
- Conditions
- HIV-1-infection
- Being tested
- EBT-101
- Keywords
- CRISPR, Gene Therapy, adeno-associated virus serotype 9 (AAV9)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBT-101Biological
Long term follow up of participants who received EBT-101
| Study group | Role | What they receive |
|---|---|---|
| Long Term Follow Up | Experimental | Participants who received EBT-101 in a parent study will undergo long term follow up Receives: Biological: EBT-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start11 Jul 2023
- Primary completionJan 2037 (estimated)
- Study completionApr 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Long term follow up of participants who received EBT-101
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excision BioTherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Kennedy, MD, Study director, Excision BioTherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143307
- Sponsor's protocol ID
- EBT-101-002
- Status last verified
- May 2024
- First submitted
- 22 Nov 2021
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up Study of HIV-1 Infected Adults Exiting a Parent Study Where EBT-101 Was Administered
- ClinicalTrials.gov ID
- NCT05143307
- Acronym / sponsor ID
- EBT-101-002
- Conditions
- HIV-1-infection
- Keywords
- CRISPR, Gene Therapy, adeno-associated virus serotype 9 (AAV9)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Excision BioTherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- Jan 2037 (estimated)
- Study completion
- Apr 2037 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Long term follow up of participants who received EBT-101
| Arm | Type | Receives |
|---|---|---|
| Long Term Follow Up | Experimental | Biological: EBT-101Participants who received EBT-101 in a parent study will undergo long term follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing and able to provide written, signed informed consent
- Participants who received the investigational study intervention EBT-101 in a parent study
Key exclusion criteria (1 listed)
- Participants who did not receive EBT-101 in a parent study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBT-101Long term follow up of participants who received EBT-101 | Biological | Long Term Follow Up |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Kennedy, MD study director
Excision BioTherapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EBT-101 in people with HIV-1-infection, run by Excision BioTherapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety of EBT-101 (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.