Study of EBT-101 in Aviremic HIV-1 Infected Adults on Stable ART
- Registration Number
- NCT05144386
- Lead Sponsor
- Excision BioTherapeutics
- Brief Summary
This is a First in Human (FIH) study of EBT-101 administered IV to aviremic HIV-1 infected adults on stable antiretroviral therapy (ART).
- Detailed Description
This is a FIH, open-label, sequential cohort, single ascending dose (SAD) study of EBT-101 administered IV to aviremic HIV-1 infected adults on stable ART.
Participants will be asked to attend several visits for screening to determine eligibility. On Day 1, eligible participants will receive a single IV dose of EBT-101. All participants will be assessed for eligibility for an analytical treatment interruption (ATI) of their background ART at Week 12. All participants will be followed through Week 48 (end of study). Participants are required to attend multiple study visits at the clinical site including daily visits for the first 14 days, followed by weekly visits after Week 12 for ATI participants. Non-ATI participants are followed monthly after Week 12.
Eligible participants who are enrolled in the FIH study (EBT-101-001) will also be enrolled in a separate Long Term Follow Up (LTFU) study (EBT-101-002) for safety monitoring. The duration of the LTFU study is 15 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description EBT-101 Dose-Level 1 EBT-101 Cohort A: Participants will be administered dose-level 1 of EBT-101 EBT-101 Dose-Level 2 EBT-101 Cohort B: Participants will be administered dose-level 2 of EBT-101
- Primary Outcome Measures
Name Time Method Safety and Tolerability of EBT-101 48 weeks Safety and tolerability of EBT-101 will be assessed based on the incidence and severity of adverse events (AEs) according to Division of AIDS (DAIDS) 2017 over 48 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Washington University
🇺🇸Saint Louis, Missouri, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Cooper Health
🇺🇸Camden, New Jersey, United States