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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01013415

Acronym

CD4-ZETA

Enrollment

Registered

2009-11-13

Start date

2001-09-30

Completion date

2021-08-31

Last updated

2022-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1 Infections

Keywords

HIV-1

Brief 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).

Detailed 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.

Interventions

DRUGHAART

BIOLOGICALT cells

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.)

Design outcomes

Primary

Measure	Time frame	Description
Safety of CD4-zeta T cells with and without IL-2 in the setting of HAART	Through study completion, an average of 1 year	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).
Effect of IL-2 on the Persistence of CD4-zeta T cells	Through study completion, an average of 1 year	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).
To compare the viral load of subjects from baseline to the end of study.	Through study completion, an average of 1 year	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026