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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01013415
Recruitment Status : Active, not recruiting
First Posted : November 13, 2009
Last Update Posted : March 10, 2020
Information provided by (Responsible Party):
University of Pennsylvania

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). 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 or disease Intervention/treatment Phase
HIV-1 Infections Drug: HAART Biological: T cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : September 2001
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ARM 1
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
Other Name: ARM 1, ARM 2, ARM 3

Biological: T cells
Other Name: ARM 2, ARM 3

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 :
  1. Determine the enhancing effect of CD4-zeta infusions on lymphocyte function [ Time Frame: End of Study ]
  2. Determine effect of IL-2 on CD4 naive and memory lymphocytes [ Time Frame: End of Study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01013415

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United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: Naomi Aronson, MD Walter Reed Army Medical Center
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Responsible Party: University of Pennsylvania Identifier: NCT01013415    
Other Study ID Numbers: WU #8829-99
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Keywords provided by University of Pennsylvania: