Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-10 @ 9:41 PM
Study NCT ID:
NCT02208167
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2014-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of HIV 1 Antigen Expanded Specific T Cell Therapy
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
IGHID 1320 - A Phase I Study to Evaluate the Safety, Immunologic, and Virologic Responses of HIV-1 Antigen Expanded Specific T Cell Therapy (HXTC) as a Therapeutic Strategy in HIV-Infected Individuals Started on Antiretroviral Therapy During Acute and Chronic Infection
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HXTC
Brief Summary:
This is a phase 1, single-site study is to evaluate the safety and immunologic and virologic efficacy of ex vivo expanded HIV-1 multi-antigen specific T-cell (HXTC) therapy in HIV-infected individuals with viral suppression on antiretroviral therapy (ART).
Detailed Description:
The main hypothesis of this study is that the administration of autologous ex vivo expanded HIV-specific T-cells (HXTCs) primed to recognize multiple HIV-1 antigens in HIV-infected participants who initiated ART during acute and chronic HIV infection will be safe, increase HIV-1 antigen specific T-cell immune responses and decrease low level viremia.
In addition, secondary objectives are to:
1. Determine the feasibility of manufacturing HXTC from participants who started cART during acute and chronic HIV infection.
2. Explore the ability of autologous ex vivo expanded HIV-1 specific T-cells (HXTC) to increase HIV-1 specific immune responses in participants initiated on cART during acute and chronic HIV infection.
3. Explore the ability of autologous ex vivo expanded HIV-1 specific T-cells (HXTC) to impact latent HIV infection as measured by a quantitative viral outgrowth assay (QVOA) and integrated proviral DNA quantification, and low level viremia as measured by a single copy assay (SCA) in participants initiated on cART during acute and chronic HIV infection.
In addition, secondary objectives are to:
1. Determine the feasibility of manufacturing HXTC from participants who started cART during acute and chronic HIV infection.
2. Explore the ability of autologous ex vivo expanded HIV-1 specific T-cells (HXTC) to increase HIV-1 specific immune responses in participants initiated on cART during acute and chronic HIV infection.
3. Explore the ability of autologous ex vivo expanded HIV-1 specific T-cells (HXTC) to impact latent HIV infection as measured by a quantitative viral outgrowth assay (QVOA) and integrated proviral DNA quantification, and low level viremia as measured by a single copy assay (SCA) in participants initiated on cART during acute and chronic HIV infection.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5U19AI096113-05 | NIH | None | https://reporter.nih.gov/quic… | View |