HIV Infection Clinical Trial
Official title:
A Phase I/II Pilot Study of the Safety of the Adoptive Transfer of Syngeneic Gene-Modified Cytotoxic T Lymphocytes in HIV Infected Identical Twins
Certain patients enrolled in NIH protocol 94-I-0206 at the Clinical Center may be eligible
to participate in one or more of the following new options:
- Donor/recipient extension phase - Both the recipient (HIV-infected twin) and donor
(non-infected twin) will participate in this extension of the CD4-zeta gene therapy
study. It will evaluate the safety and activity of infusing gene-modified CD4+ cells as
well as the modified CD8+ cells.
- Corticosteroid administration - A corticosteroid, such as prednisone, hydrocortisone or
prednisolone, will be added to the interleukin-2 (IL-2) regimen for preventing or
treating side effects of IL-2 such as fever and other flu-like symptoms.
- Extended follow-up - A more intensive follow-up will be scheduled for patients with
substantial numbers of lymphocytes that harbor the CD4-zeta gene. Every 3 months,
participants will have blood tests and specialized tests of CD4 counts, HIV-1 viral
load and numbers of circulating cells containing the CD4-zeta gene every 3 months> the
frequency of follow-up visits may be reduced as time goes by.
- IL-2 continuation - Participants will continue to receive periodic treatment with IL-2
to see how long the genetically modified cells persist in the bloodstream and to
evaluate the long-term response to IL-2.
- Home treatment with interleukin-2 - Participants may receive future IL-2 treatment
cycles at home. Home treatment involves less frequent data and safety monitoring and no
medical evaluations at the Clinical Center except at the beginning of each cycle.
Open-label, comparative, sequentially randomized treatment with genetically unmodified or modified ex vivo-expanded T-lymphocytes in patients with HIV infection who possess a seronegative syngeneic twin. Genetic modification consists of introduction of a gene for HLA-unrestricted "universal" receptors specific for the gp120 HIV envelope protein. Treatment is divided into Periods I and II. ;
Endpoint Classification: Safety Study, Primary Purpose: Treatment
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