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Trial record 19 of 28 for:    " November 01, 2009":" December 01, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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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
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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
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:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Interleukin-2
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013