Trial Search Results

Safety and Efficacy of T Cell Genetic Immunotherapy for HIV

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

VIRxSYS Corporation

Stanford Investigator(s):

Intervention(s):

  • Genetic: VRX496-Modified Autologous T cells

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Debbie Slamowitz
650-723-2804
Not Recruiting