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

Tracking Information

First Received Date ^ICMJE

November 5, 2009

Last Updated Date

January 31, 2013

Start Date ^ICMJE

September 2001

Estimated Primary Completion Date

June 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01013415 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

HIV-1 Infections

Intervention ^ICMJE

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

Study Arm (s)

Experimental: ARM 1
Patients continue HAART and receive low dose IL-2 (~1.2M IU/m2) sq daily x 56 days

Intervention: Drug: IL-2 (~1.2M IU/m2)
Experimental: ARM 2
Patients continue HAART and receive an infusion of 5-10 x E9 T cells by IV infusion.

Intervention: Biological: T Cell infusion 5-10 x E9 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.
Interventions:
- Drug: IL-2 (~1.2M IU/m2)
- Biological: T Cell infusion 5-10 x E9 T cells

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2016

Estimated Primary Completion Date

June 2015 (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.)

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01013415

Other Study ID Numbers ^ICMJE

WU #8829-99

Has Data Monitoring Committee

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

Information Provided By

University of Pennsylvania

Verification Date

January 2013

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

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