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Enrolling by invitation NCT05143307

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

Phase I Interventional HIV-1-infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EBT-101.
Who it may be relevant to
Registry conditions: HIV-1-infection. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Long-Term Follow-Up Study of HIV-1 Infected Adults Exiting a Parent Study Where EBT-101 Was Administered

Overview

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

  • Biological EBT-101
    Long term follow up of participants who received EBT-101

Primary outcome measures

  • Long-term safety of EBT-101 [Time frame: 15 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 3 centers
  • Quest Clinical Research — San Francisco
  • Washington University — St Louis
  • Cooper Health — Camden

Identifiers

NCT: NCT05143307 · EBT-101-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗