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Status:

TERMINATED

Gene Transfer for HIV Using Autologous T Cells

Lead Sponsor:

City of Hope Medical Center

Conditions:

HIV-1 Infection

Eligibility:

All Genders

18-60 years

Phase:

EARLY_PHASE1

Brief Summary

This is a pilot study to determine the safety and feasibility of lentivirus-transduced T-cell immunotherapy in patients who have failed highly active anti-retrovirus therapy (HAART).

Detailed Description

Study Design This is a pilot study to determine the safety and feasibility of lentivirus-transduced T cell immunotherapy in patients who have failed highly active anti-retrovirus therapy (HAART) as de...

Eligibility Criteria

Inclusion

  • Patient must:
  • Be Age ≥ 18 years ≤ 60 years.
  • Be HIV seropositive and have been treated with a potent antiretroviral chemotherapy regimen for at least one year and with an HIV plasma RNA \>5000 gc/ml.
  • Have available genotypic evidence of resistance and prior HAART modifications must have been consistent with current recommendations.
  • Have a CD4 count \>200 cells/mL and a CD4/CD8 ratio \>0.2, with hemoglobin, WBC, and platelet count within 1.5x normal limits.
  • Have a Karnofsky performance status \>/= 70%.
  • Have pretreatment SGOT, SGPT, and serum bilirubin \<2.5 times the institutional upper limit of normal (ULN) with no extrinsic hepatobiliary disease and no HBV surface antigen and no hepatitis C virus antibody.
  • Have PT/PTT \<2 times the ULN.
  • Have serum creatinine \< 2 x ULN.
  • Females Only: Must not be pregnant based on a pregnancy test within the past 7 days.
  • Have CD4 counts are ≤ 200, is the patient on a prophylactic regimen for pneumocystis pneumonia or have they agreed to begin such treatment.
  • Agree to use effective birth control to prevent pregnancy.
  • Voluntarily consent and comply with the treatment and required tests.

Exclusion

  • Patients are ineligible if:
  • The patient has an active bacterial or fungal infection.
  • The patient has been successfully treated AIDS related opportunistic infections within the past year.
  • The patient has active CMV retinitis or other active CMV-related organ dysfunction (excluding completely treated CMV infections).
  • The patient has evidence of clinically significant neuropathy.
  • The patient has had a relapse of pneumocystis carinii pneumonia within the past year.
  • The patient has intractable and severe diarrhea as defined as \>1500 cc diarrheal fluid per day or diarrhea causing persistent severe electrolyte abnormalities or hypoalbuminemia.
  • The patient has other AIDS-related syndromes, infections or other illness that would preclude autologous HCT as determined by the Principle Investigator.
  • The patient has taken any immunosuppressive medications in the past 30 days.
  • Has any prior malignancy, except those treated with curative intent that are five years from treatment, cervical and anal squamous cell cancers and superficial basal cell and squamous cell cancers of the skin.
  • The patient has auto-antibodies.
  • The patient has had a leukapheresis in the past 3 months.
  • The patient has a known allergy to human serum albumin, Dextran 40 or DMSO.
  • The patient has ever been on a gene therapy trial.

Key Trial Info

Start Date :

April 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2011

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT01153646

Start Date

April 1 2010

End Date

January 1 2011

Last Update

January 19 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Beckman Research Institute of City of Hope

Duarte, California, United States, 91010