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

NCT01013415 | Completed Phase 1

• 1 other identifier: WU #8829-99
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV-1 Infections

Keywords

HIV-1

Outcome Measures

Primary Outcomes (3)

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

  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).

  Through study completion, an average of 1 year

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

  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).

  Through study completion, an average of 1 year

• To compare the viral load of subjects from baseline to the 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) at study specific timepoints.

  Through study completion, an average of 1 year

Study Arms (3)

ARM 1

EXPERIMENTAL

Arm I (N=5) received antiretroviral therapy (ART) plus low dose IL-2 (1.2 million units/m2) subcutaneously daily for 56 days

Drug: HAART

ARM 2

EXPERIMENTAL

Arm 2 (N=5) received ART plus a single infusion of approximately 5 to 11 billion CD4-zeta gene modified T cells.

Biological: T cells

ARM 3

EXPERIMENTAL

Arm 3 (n=5) received ART plus IL-2 (1.2 million units/m2) and a single infusion of approximately 5 to 11 billion CD4-zeta gene modified T cells.

Drug: HAART; Biological: T cells

Interventions

HAART DRUG

Also known as: ARM 1, ARM 2, ARM 3

ARM 1; ARM 3

T cells BIOLOGICAL

Also known as: ARM 2, ARM 3

ARM 2; ARM 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Walter Reed Army Medical Center

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

Location

MeSH Terms

Interventions

Antiretroviral Therapy, Highly Active

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Naomi Aronson, MD

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 13, 2009
• Study Start: September 1, 2001
• Primary Completion: June 1, 2005
• Study Completion: August 1, 2021
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)