Redirected High Affinity Gag-Specific Autologous T Cells for HIV Gene Therapy
HIV Infections
About this trial
This is an interventional basic science trial for HIV Infections focused on measuring HIV, HIV therapeutic vaccine
Eligibility Criteria
Inclusion Criteria:
- Age 18 years or older
- Karnofsky Performance of 80 or higher
- HLA-A2 Positive
- Chronic HIV-1 infection
- On stable HAART regimen (with no changes within 4 weeks of study entry)
- Willing to undergo a limited treatment interruption of antiretroviral medication
- CD4+ T cell count ≥450 cells/mm3
- Documented CD4 nadir of ≥200 cells/mm3
- Undetectable HIV-1 RNA
- ARMS 1 and 2 only, at least a singe documented historic viral load set point reading
- Lab Values: Hgb≥10 males; ≥9.5 females ; ANC≥1000/mm3 ; Platelets≥1000,000/mm3 ; Creatinine≤1.5 mg/dL ; AST, ALT ≤ 2.5xULN
Exclusion Criteria:
- Current or prior AIDS diagnosis
- Previous participation in any gene therapy using an integrating vector (subjects treated with Placebo will not be excluded)
- History of cancer or malignancy (allowed to have successfully treated basal cell or squamous cell carcinoma of the skin)
- Have history or current exam indicative of active or unstable cardiac disease or hemodynamic instability
- Have history or current exam indicative of bleeding diathesis
- Previous treatment with any HIV experimental vaccine within 6 months prior to screening
- Use of chronic corticosteroids, hydroxyurea or immunomodulating agents such as IL2, interferon alpha, interferon gamma, granulocyte colony stimulating factors within 30 days prior to study entry (inhaled steroids are not exclusionary)
- Currently breast feeding, pregnant or unwilling to use acceptable methods of birth control
- Use of aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2 week period prior to leukapheresis
- Active drug or alcohol use/dependence
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry
- Receipt of a vaccination within 30 days prior to study entry
- Have a known allergy or hypersensitivity to human serum albumin, DMSO or Dextran 40
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm 1
Arm 2
Arm 3
Arm 4
Subjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 at the time of enrollment, a CD4 nadir >200 and a recorded historical viral load setpoint, will receive a WT-gag-TCR modified autologous T cells, followed one week later by a 16 week treatment interruption.
Subjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 at the time of enrollment, a CD4 nadir >200 and a recorded historical viral load setpoint, will receive a α/6-gag-TCR modified autologous T cells, followed one week later by a 16 week treatment interruption.
Subjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 and a CD4 nadir >200. Subject will undergo an 16 week treatment interruption during which a single infusion of WT-gag-TCR modified autologous T cells at 8 weeks post STI.
Subjects who are HIV positive, taking medication to control virus, have an undetectable viral load, CD4 count greater than 450 and a CD4 nadir of >200. Subject will undergo a 16-week treatment interruption during which a single infusion of α/6-gag-TCR modified autologous T cells at 8 weeks post STI.