Clinical Trial

Disease: Human Immunodeficiency Virus Infection, HIV (NCT05144386)

Disease info:

HIV stands for human immunodeficiency virus. It harms the immune system by destroying the white blood cells that fight infection, putting infected individuals at risk for serious infections and certain cancers. AIDS stands for acquired immunodeficiency syndrome. It is the final stage of infection with HIV. Not everyone with HIV develops AIDS.

Frequency:
Worldwide, there were about 1.7 million new cases of HIV in 2018. About 37.9 million people were living with HIV around the world in 2018, and 23.3 million of them were receiving medicines to treat HIV, called antiretroviral therapy (ART).
Official title:
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
Who:

Contact: William Kennedy, MD 833-214-2241 clinicalscience@excisionbio.com

 

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:
Jan. 24, 2022
Enrollment:
9
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene disruption
Gene:
Three undisclosed genomic sites in the HIV DNA
Delivery method:
AAV9 - In-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/NCT05144386
Safety updates:

(22-11-2022) 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

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

Status: Active recruiting

Description

This is a First in Human (FIH), open-label, sequential cohort, single ascending dose (SAD) study of EBT-101 administered IV to aviremic HIV-1 infected adults on stable antiretroviral therapy (ART).

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; participants who undergo ATI will have more frequent study visits than non-ATI participants.

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 will be up to 15 years.

Last updated: Jun. 5, 2023
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