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Enrolling by Invitation

NCT Number: NCT05143307

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

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).

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quest Clinical Research, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EBT-101

Biological

Long term follow up of participants who received EBT-101

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Excision BioTherapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2037
Study completion
2037
First posted
Dec 3, 2021
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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