CD4-ZETA Gene Modified T Cells With and Without Exogenous Interleukin-2 (IL-2) In HIV Patients

HIV-1 Infections Clinical Trial

— CD4-ZETA  

Official title:

A Phase I/II Study Of the Safety, Survival, and Trafficking of Autologous CD4-ZETA Gene-Modified T Cells With and Without Extension Interleukin-2 in HIV Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013415
• Other study ID #: WU #8829-99
• Status: Completed
• Phase: Phase 1
• Start date: September 2001
• Est. completion date: August 2021

Study information

• Verified date: August 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2).

Description:

The purpose of this study is to find out the safety and activity of an experimental anti-HIV treatment using autologous CD4-zeta gene-changed T cells and/or IL-2 (recombinant interleukin2). The treatments that the investigators are studying try to improve the immune system by changing some of your T cells so they can find and destroy HIV infected cells (HIV is usually able to hide from your T cells). In this study, the investigators are also trying to find out if giving you more IL-2 at the same time as gene changed T cells will help the T cells to live longer or fight HIV better.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2021
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• DOD beneficiary with HIV-1 infection
• Greater than or equal to 200 CD4 cells/mm3
• Undetectable viral load, for at least the previous 8 weeks
• Stable anti-retroviral regimen for greater than or equal to 8 weeks
• Venous access sufficient for apheresis
• Karnofsky performance > 80%

Exclusion Criteria:

• Inadequate organ function
• Lifetime history of CD4 count less than 200 cells/mm3 on 2 consecutive measurements over at least an 8 week period
• Any previous history of gene therapy
• Recent IL-2 therapy or other treatment with an investigational agent
• Pregnancy
• some medications (hydroxyurea, corticosteroids and other immunosuppressants, chemotherapy, etc.)

Related Conditions & MeSH terms

• HIV-1 Infections

Intervention

Drug:
• HAART

Biological:
• T cells

Locations

Country	Name	City	State
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of CD4-zeta T cells with and without IL-2 in the setting of HAART	To assess and compare the safety of each arm when comparing related adverse events reported of subjects on study through the end of study (week 54).	Through study completion, an average of 1 year
Primary	Effect of IL-2 on the Persistence of CD4-zeta T cells	Subjects who received IL-2 plus gene-modified cells versus those who received cells alone will have greater numbers gene-modified cells in both PBMCs and rectal lymphoid tissue. This will be done by quantifying residual virus in the reservoir using more modern techniques that permit quantification of small amounts of virus in the rectal lymphoid tissue and to quantify specifically replication competent HIV (versus total HIV).	Through study completion, an average of 1 year
Primary	To compare the viral load of subjects from baseline to the end of study.	Determine the effect of CD4-zeta infusions with and without IL-2 on viral load (plasma HIV-1 RNA, tissue HIV-1 RNA, and frequency of latent replication-competent HIV-1 in PBMC) at study specific timepoints.	Through study completion, an average of 1 year