CD4-ZETA Gene Modified T Cells With and Without Exogenous Interleukin-2 (IL-2) In HIV Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/9/2019 |
| Start Date: | September 2001 |
| End Date: | July 2021 |
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 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.
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.)
We found this trial at
1
site
6900 Georgia Ave NW
Washington, District of Columbia 20307
Washington, District of Columbia 20307
(202) 782-6849
Walter Reed Army Medical Center The Walter Reed National Military Medical Center is one of...
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