Status:
COMPLETED
Evaluate the Tolerability and Therapeutic Effects of Repeated Doses of Autologous T Cells With VRX496 in HIV
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study is intended for individuals who are doing well on HAART therapy. In Step 1 of the trial, individuals will be given up to 6 infusions of the study drug VRX496 to see the effect on viral load ...
Detailed Description
HIV-based antisense vectors may provide several important advantages over current HIV combination therapies. VIRxSYS Corporation (VIRxSYS) is developing the candidate clinical vector VRX496. VRX496 is...
Eligibility Criteria
Inclusion
- HIV-1 positive by western blot or detection of HIV RNA in blood and responding to combination antiviral therapy
- No changes in antiretroviral medications within past 4 weeks of study entry and willing to continue on current therapy for the duration of the study
- 18 years of age and older
- Karnofsky Performance score of greater than 80
- HIV viral load \< 59 copies/mL
- CD4 T cell count \> 350 cells per uL
- adequate venous access
Exclusion
- HIV seroconversion within past year
- History of cancer (other than a removed basal or squamous cell of the skin)
- History of congestive heart failure.
- Previous treatment with HIV experimental vaccine within past year
- Previous treatment with any gene therapy
- Positive serology for Vesicular Stomatitis Virus (VSV-G or VSV-G DNA)
- Currently breastfeeding, pregnant, or unwilling to use birth control
- Using oral corticosteroids, hydroxyurea, or immunomodulating agents (IL-2, interferon-gamma, granulocyte colony stimulating factors, megestrol acetate) within the past 30 days or foresee the need to use these during the study period.
- Are presently drug or alcohol dependent
- Have other serious illness or acute opportunistic infection or bacterial infection requiring systemic treatment and/or hospitalization within the past 30 days
- Have chronic hepatitis B or hepatitis C
- Have an active AIDS defining illness
- Have an allergy or hypersensitivity to human serum albumin, DMSO or Dextran 40
- Have diabetes or a coagulopathy with in the opinion of the investigator would exclude subjects from participating in rectal biopsy.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00295477
Start Date
January 1 2006
End Date
December 1 2013
Last Update
October 23 2019
Active Locations (1)
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1
University of Pennsylania
Philadelphia, Pennsylvania, United States, 19104