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Completed

NCT Number: NCT01013415

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

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).

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Key information

Conditions

HIV-1 Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

HAART

Drug

Other names: ARM 1, ARM 2, ARM 3

T cells

Biological

Other names: ARM 2, ARM 3

Primary outcomes

  1. Safety of CD4-zeta T cells with and without IL-2 in the setting of HAART

    Time frame: Through study completion, an average of 1 year

    To assess and compare the safety of each arm when comparing related adverse events reported of subjects on study through the end of study (week 54).

  2. Effect of IL-2 on the Persistence of CD4-zeta T cells

    Time frame: Through study completion, an average of 1 year

    Subjects who received IL-2 plus gene-modified cells versus those who received cells alone will have greater numbers gene-modified cells in both PBMCs and rectal lymphoid tissue. This will be done by quantifying residual virus in the reservoir using more modern techniques that permit quantification of small amounts of virus in the rectal lymphoid tissue and to quantify specifically replication competent HIV (versus total HIV).

  3. To compare the viral load of subjects from baseline to the end of study.

    Time frame: Through study completion, an average of 1 year

    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) at study specific timepoints.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study 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

Acronym: CD4-ZETA

Important dates

Study start
2001
Primary completion
2005
Study completion
2021
First posted
Nov 13, 2009
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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