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CD4-ZETA Gene Modified T Cells With and Without Exogenous Interleukin-2 (IL-2) In HIV Patients (CD4-ZETA)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Pennsylvania
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01013415
First received: November 5, 2009
Last updated: July 5, 2017
Last verified: July 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV-1 Infections | Drug: HAART Biological: T cells | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- To assess the safety/tolerability/feasibility of administering autologous CD4-zeta gene modified T cells IV in a setting of highly active antiretroviral therapy (HAART) w & w/o IL-2 at a dose of ~1.2 M IU/m2 SQ daily for 56 days [ Time Frame: Day 56 ]
- Assess the effect of daily subcutaneous IL-2 on the persistence and trafficking of CD4-zeta gene modified T cells in the circulation and lymphoid (rectal) tissue [ Time Frame: 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). [ Time Frame: End of Study ]
Secondary Outcome Measures:
- Determine the enhancing effect of CD4-zeta infusions on lymphocyte function [ Time Frame: End of Study ]
- Determine effect of IL-2 on CD4 naive and memory lymphocytes [ Time Frame: End of Study ]
| Enrollment: | 17 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | July 2021 |
| Estimated Primary Completion Date: | July 2021 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ARM 1
HAART, IL-2
|
Drug: HAART
Other Name: ARM 1, ARM 2, ARM 3
|
|
Experimental: ARM 2
HAART, T cells
|
Biological: T cells
Other Name: ARM 2, ARM 3
|
|
Experimental: ARM 3
HAART, IL-2, T cells
|
Drug: HAART
Other Name: ARM 1, ARM 2, ARM 3
Biological: T cells
Other Name: ARM 2, ARM 3
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013415
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013415
Locations
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, D.C., District of Columbia, United States, 20307 | |
Sponsors and Collaborators
University of Pennsylvania
Investigators
| Principal Investigator: | Naomi Aronson, MD | Walter Reed Army Medical Center |
More Information
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01013415 History of Changes |
| Other Study ID Numbers: |
WU #8829-99 |
| Study First Received: | November 5, 2009 |
| Last Updated: | July 5, 2017 |
Keywords provided by University of Pennsylvania:
|
HIV-1 |
Additional relevant MeSH terms:
|
Interleukin-2 Antineoplastic Agents Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 17, 2017