Evaluate the Tolerability and Therapeutic Effects of Repeated Doses of Autologous T Cells With VRX496 in HIV

Completed · Phase 1

Conditions studied: HIV

In brief

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 and CD4 counts. If individuals have no serious adverse effects from the infusions of VRX496 and the viral load and CD4 counts remain stable, they may go on to Step 2 of the study. In Step 2, individuals will stop taking their HAART medication and their viral load, CD4 counts and the number of VRX496 in T cells will be monitored. All subjects who receive VRX496 T cells will enroll in a Long-Term Follow-up study to monitor subjects. Subjects will be followed every 6 months for five years following the 1st infusion of the T cells. If the VRX496 T cells are no longer found in the blood after five years, then subjects will be contacted yearly for the next 10 years. If the VRX496 T cells are found in the blood at five years after the 1st infusion of T cells, then the subjects will continue to be seen once a year until the VRX496 T cells are no longer found in the blood for a maximum of 15 years.

Key facts

Study ID

NCT00295477

Run by

University of Pennsylvania

People needed

25

Starts

2006-01-01

Expected to finish

2013-12-01

Last updated by the study team

2019-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Pennsylania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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