Safety and Efficacy of T Cell Genetic Immunotherapy for HIV

Status unconfirmed · Phase 2

Conditions studied: HIV Infection

In brief

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.

Key facts

Study ID

NCT00131560

Run by

VIRxSYS Corporation

People needed

60

Starts

2005-07-01

Expected to finish

2023-06-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford AIDS Clinical Trials Unit — Palo Alto, California, United States
• CIRCLE Medical, LLC — Norwalk, Connecticut, United States
• Steinhart Medical Associates — Miami, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States
• Jacobi Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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