A Phase 1/2a, Sequential Cohort, Single Ascending Dose Study of the Safety, Tolerability, Biodistribution, and Pharmacodynamics of EBT 101 in Aviremic HIV-1 Infected Adults on Stable Antiretroviral Therapy

This is a First in Human (FIH) study of EBT-101 administered IV to aviremic HIV-1 infected adults on stable antiretroviral therapy (ART).

Eligble participants will receive a single intravenous (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 and followed for up to 1 years after receiving EBT-101.

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.

Sponsor

Excision BioTherapeutics

Status of enrollment

Accepting new patients

Ages Eligible for Study

Ages 18-65

Genders Eligible for Study

Males

Disease indication

HIV-1-infection

Principal Investigator

Priscilla Hsue, MD

Contact

Danny Li, MS PA-C: [email protected]

Marta Levkova: [email protected]

 

Additional study eligibility details can be found at UCSF Clinical Trials.