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

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 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.

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.)