Status:
COMPLETED
Redirected High Affinity Gag-Specific Autologous T Cells for HIV Gene Therapy
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Adaptimmune
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This research study is being carried out to study a new way to possibly treat HIV. T-cells are one of the white blood cells used by the body to fight HIV. CD8 T-cells are a type of T-cell used by the ...
Detailed Description
See Above
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00991224
Start Date
November 1 2009
End Date
January 1 2014
Last Update
October 10 2019
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104