HIV-1-infection
Conditions
Keywords
CRISPR, Gene Therapy, adeno-associated virus serotype 9 (AAV9)
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.
Interventions
BIOLOGICALEBT-101
Long term follow up of participants who received EBT-101
Sponsors
Excision BioTherapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Long term follow up of participants who received EBT-101
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
• Participants who did not receive EBT-101 in a parent study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety of EBT-101 | 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 |
Countries
United States
Outcome results
None listed