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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01013415
First received: November 5, 2009
Last updated: January 31, 2013
Last verified: January 2013
  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: IL-2 (~1.2M IU/m2)
Biological: T Cell infusion 5-10 x E9 T cells
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the enhancing effect of CD4-zeta infusions on lymphocyte function [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • Determine effect of IL-2 on CD4 naive and memory lymphocytes [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2001
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM 1
Patients continue HAART and receive low dose IL-2 (~1.2M IU/m2) sq daily x 56 days
Drug: IL-2 (~1.2M IU/m2)
IL-2 (~1.2M IU/m2) sq daily x 56 days
Experimental: ARM 2
Patients continue HAART and receive an infusion of 5-10 x E9 T cells by IV infusion.
Biological: T Cell infusion 5-10 x E9 T cells
Single infusion of T cells
Experimental: ARM 3
Patients continue HAART and receive an infusion of 5-10 E9 T cells by IV infusion and low dose IL-2 (~1.2M IU/m2) sq daily x 56 days.
Drug: IL-2 (~1.2M IU/m2)
IL-2 (~1.2M IU/m2) sq daily x 56 days
Biological: T Cell infusion 5-10 x E9 T cells
Single infusion of T cells

  Eligibility

Genders Eligible for Study:   Both
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

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, 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

No publications provided

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: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Infection with HIV-1 with undetectable viral load on HAART therapy

Additional relevant MeSH terms:
Infection
Interleukin-2
Analgesics
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014