Overview

This trial is active, not recruiting.

Condition hiv-1 infections
Treatments il-2 (~1.2m iu/m2), t cell infusion 5-10 x e9 t cells
Phase phase 1
Sponsor University of Pennsylvania
Start date September 2001
End date June 2015
Trial size 24 participants
Trial identifier NCT01013415, WU #8829-99

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients continue HAART and receive low dose IL-2 (~1.2M IU/m2) sq daily x 56 days
il-2 (~1.2m iu/m2)
IL-2 (~1.2M IU/m2) sq daily x 56 days
(Experimental)
Patients continue HAART and receive an infusion of 5-10 x E9 T cells by IV infusion.
t cell infusion 5-10 x e9 t cells
Single infusion of T cells
(Experimental)
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.
il-2 (~1.2m iu/m2)
IL-2 (~1.2M IU/m2) sq daily x 56 days
t cell infusion 5-10 x e9 t cells
Single infusion of T cells

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants of any age.

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.)

Additional Information

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
Principal investigator Naomi Aronson, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by University of Pennsylvania.