Clinical Trial

Disease: Human Immunodeficiency Virus Infection, HIV (NCT05143307)

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

Excision BioTherapeutics

Partners:

None

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
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:

(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: Sep. 8, 2023
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