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

University of Pennsylvania

Status and phase: Completed; Phase 1

Conditions: HIV-1 Infections

Treatments: Drug: HAART; Biological: T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01013415

WU #8829-99

Details and patient eligibility

About

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).

Full 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.

Enrollment: 17 patients

Sex: All

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

ARM 1

Experimental group

Description:

Arm I (N=5) received antiretroviral therapy (ART) plus low dose IL-2 (1.2 million units/m2) subcutaneously daily for 56 days

Treatment:

Drug: HAART

ARM 2

Experimental group

Description:

Arm 2 (N=5) received ART plus a single infusion of approximately 5 to 11 billion CD4-zeta gene modified T cells.

Treatment:

Biological: T cells

ARM 3

Experimental group

Description:

Arm 3 (n=5) received ART plus IL-2 (1.2 million units/m2) and a single infusion of approximately 5 to 11 billion CD4-zeta gene modified T cells.

Treatment:

Biological: T cells

Drug: HAART