Clinical Trial

Disease: Human Immunodeficiency Virus Infection, HIV, (NCT05143307)

Disease info:

Human immunodeficiency virus (HIV) is a virus that attacks the immune system by infecting and killing white blood cells known as CD4+ T-cells. CD4+ T-cells represent a vital part of the immune system and untreated HIV infections render patients more vulnerable to dangerous infections by other pathogens, including bacteria and fungi. If the virus remains untreated it can lead to patients developing the life-threatening disease acquired immunodeficiency syndrome (AIDS). Untreated HIV can leave people vulnerable to life-threatening infections. HIV symptoms often manifest as flu-like symptoms such as fever, chills, rash, night sweats, muscle aches, sore throat, and fatigue. Today, antiviral medications can allow people living with HIV to live healthy lives.

Frequency:
In 2021, 36,136 people received an HIV diagnosis in the United States and dependent areas. An estimated 1.2 million people in the United States had HIV at the end of 2021.
Official title:
Long-Term Follow-Up Study of HIV-1 Infected Adults Exiting a Study Where EBT-101 Was Administered
Who:
Sponsor:

Excision BioTherapeutics

Partners:
Locations:

United States, California

University of California San Francisco, San Francisco, California, United States, 94110

 

United States, Missouri

Washington University, Saint Louis, Missouri, United States, 63110

 

United States, New Jersey

Cooper Health, Camden, New Jersey, United States, 08103

Study start:
Mar. 1, 2023
Enrollment:
9 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene disruption
Gene:
Undisclosed
Delivery method:
Adenovirus-associated virus vector serotype 9 (AAV9) - In-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/NCT05143307
Safety updates:

(13-06-2024) Excision BioTherapeutics Announces Data from the Phase 1/2 Trial of EBT-101 in HIV And In Vivo Efficacy Data in Herpes Virus and Hepatitis B

(22-09-2022) First patient dosed with HIV gene therapy

(27-01-2022) Excision BioTherapeutics Initiates Phase 1/2 Trial Evaluating EBT-101 as a Potential Cure for HIV

(15-09-2021) Excision Receives FDA Clearance of IND for Phase 1/2 Trial of EBT-101 CRISPR-Based Therapeutic for Treatment of HIV

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Enrolling by invitation

Description

Participants who receive EBT-101 in a treatment protocol as part of a Phase 1 trial for HIV will be eligible to participate in this long-term follow-up (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.

Last updated: May. 20, 2025
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