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Safety and Efficacy of T Cell Genetic Immunotherapy for HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00131560
Recruitment Status : Active, not recruiting
First Posted : August 18, 2005
Last Update Posted : June 8, 2011
Information provided by:
VIRxSYS Corporation

Brief Summary:
This study uses autologous (one's own) CD4 T cells modified with a viral vector expressing a genetic antisense targeting HIV, this vector is called VRX496. Study treatment is by intravenous infusion of vector modified cells and infusions will be provided every other week for a total of 4 or 8 doses. These modified cells, once infused, may provide immune support and are not destroyed by HIV, and thus may delay or reverse HIV disease progression. The study will enroll up to 40 male and female HIV-positive subjects in up to 8 centers. Subjects will be 18 years of age and over who have failed or are intolerant to at least one triple combination of antiretroviral drugs. Subjects must have a viral load between 5,000 and 200,000 copies/ml and a CD4+ count of ≥150, be in good health and have no evidence of active opportunistic infection, heart disease, or bleeding disorders. Subjects must not be on corticosteroids, immunomodulating agents or hydroxyurea. Subjects must not have received an AIDS vaccine or any investigational gene therapy product at any time. Females must not be pregnant or breastfeeding.

Condition or disease Intervention/treatment Phase
HIV Infection Genetic: VRX496-Modified Autologous T cells Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Biological Activity of Single and Repeated Doses of Autologous T Cells Transduced With VRX496 in HIV-Positive Subjects
Study Start Date : July 2005
Actual Primary Completion Date : November 2008
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
A Genetic: VRX496-Modified Autologous T cells
Genetic: Anti-HIV antisense

Primary Outcome Measures :
  1. Change in viral load [ Time Frame: 1 Year ]
  2. Change in CD4 counts [ Time Frame: 1 Year ]
  3. Safety [ Time Frame: 15 Years ]

Secondary Outcome Measures :
  1. Immune function [ Time Frame: 1 Year ]
  2. AIDS related illness [ Time Frame: 1 Year ]
  3. Persistence of vector modified cells [ Time Frame: 15 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sero-positive for infection with HIV and failed, or be intolerant to, at least one triple combination of antiretroviral agent
  • If on antiretroviral therapy, subject must be willing to continue on current antiretroviral therapy; or if discontinues antiretroviral therapy must have a wash-out period of 6 weeks prior to screening; or if not on antiretroviral therapy must be willing to remain off antiretroviral therapy for the duration of the study (i.e. up to 1 year)
  • Male or female, 18 years of age and older
  • Karnofsky Performance score of 80 or higher
  • Stable HIV viral load between 5,000 and 200,000 copies/mL at the time of screening. Stable will be defined as a variation of less than 0.5 log10 in the 3 months prior to screening while on a stable regimen or no therapy
  • CD4 T cell count equal to or greater than 150 cells per μL at the time of screening
  • A body weight greater than 50 Kg
  • Adequate venous access and no other contraindications for leukapheresis
  • Subject must be willing to comply with study-mandated evaluations

Exclusion Criteria:

  • A history of any type of cancer or malignancy, with the exception of (successfully) treated basal cell or squamous cell carcinoma of the skin
  • A history or any features on physical examination indicative of cardiac disease or hemodynamic instability
  • Any history or any features on physical examination indicative of a bleeding diathesis
  • Previous treatment with any HIV experimental vaccine or any gene therapy products
  • A positive signal for VSV-G antibodies and/or VSV-G DNA in the blood at screening
  • Any of the following lab results:

    • Hemoglobin: <10 (males); <9.5 (females) g/dL
    • Absolute neutrophil count: < 1000/μL
    • Platelet count: <100,000/mm3
    • Serum creatinine: > 1.5 mg/dL (133µ mol/L)
    • AST or ALT: > 2.5 times the upper limit of normal
    • Total serum bilirubin: > 1.5 times the upper limit of normal
    • Proteinuria: 2+ on urine dipstick
  • Subjects must not be breastfeeding, be pregnant, or unwilling to use acceptable methods of birth control
  • Subjects must not be on chronic oral corticosteroids within 30 days of screening - (if subjects are prescribed a brief course of oral corticosteroids the use should be limited to less than 1 week), hydroxyurea, or immunomodulating agents (e.g., IL 2, interferon-gamma, granulocyte colony stimulating factors, etc.) within 30-days of screening or foreseeably need any of these within the study period
  • Subjects must not be using aspirin, dipyridamole, warfarin or any other medication likely to affect platelet function or other aspects of blood coagulation during the period when leukapheresis is scheduled
  • Subjects must not suffer from active drug or alcohol dependence or abuse, to an extent that, in the opinion of the investigator, would interfere with their ability to comply with study requirements
  • Any serious illnesses or acute opportunistic infection
  • Any other illness or condition which in the opinion of the investigator would exclude the subject from the study
  • Subjects unable or unwilling to give written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131560

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United States, California
Stanford AIDS Clinical Trials Unit
Palo Alto, California, United States, 94304
United States, Connecticut
Norwalk, Connecticut, United States, 06851
United States, Florida
Steinhart Medical Associates
Miami, Florida, United States, 33133
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
VIRxSYS Corporation
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Study Director: Tessio Rebello, PhD VIRxSYS Corporation

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Responsible Party: Tessio Rebello/ Vice President Clinical Affairs, VIRxSYS Corporation
ClinicalTrials.gov Identifier: NCT00131560    
Other Study ID Numbers: VRX496-USA-05-002
First Posted: August 18, 2005    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Keywords provided by VIRxSYS Corporation:
HIV, gene therapy, leukapheresis, autologous CD4 T cell, lentivector
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases