Phase I Study of HIV 1 Antigen Expanded Specific T Cell Therapy — HXTC  

HIV Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• HIV

• NCT number: NCT02208167
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Completed
• Phase: Phase 1
• Start date: April 7, 2015
• Completion date: November 27, 2017