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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

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 13, 2009
Last Update Posted Date March 10, 2020
Study Start Date  ICMJE September 2001
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE CD4-ZETA Gene Modified T Cells With and Without Exogenous Interleukin-2 (IL-2) In HIV Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1 Infections
Intervention  ICMJE
  • Drug: HAART
    Other Name: ARM 1, ARM 2, ARM 3
  • Biological: T cells
    Other Name: ARM 2, ARM 3
Study Arms  ICMJE
  • Experimental: ARM 1
    HAART, IL-2
    Intervention: Drug: HAART
  • Experimental: ARM 2
    HAART, T cells
    Intervention: Biological: T cells
  • Experimental: ARM 3
    HAART, IL-2, T cells
    • Drug: HAART
    • Biological: T cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 5, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2009)
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01013415
Other Study ID Numbers  ICMJE WU #8829-99
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Naomi Aronson, MD Walter Reed Army Medical Center
PRS Account University of Pennsylvania
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP