Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals
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To investigate the safety and tolerance of an increasing number of infusions per week of alvircept sudotox ( sCD4-PE40; soluble CD4-Pseudomonas exotoxin ) at a fixed dose when administered to HIV-1-infected individuals. To investigate the effect of sCD4-PE40 on the following parameters: T lymphocyte subsets, plasma HIV RNA and cellular HIV proviral DNA in PBMC and CD4 cells, p24 levels, serum beta-2 microglobulin, and neopterin levels.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must have:
HIV positivity confirmed by Western blot.
CD4 count of 100 - 500 cells/mm3 on a morning draw within 3 weeks prior to study entry.
Patients with the following symptoms and conditions are excluded:
Concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or nondisseminated Kaposi's sarcoma.
Hemophilia or other clotting disorders.
Major organ allograft.
Significant cardiac, hepatic, renal, or CNS disease.
Antiretroviral agents within 2 months prior to study entry.
Known anti-HIV medication within 60 days prior to study entry.
Prior immunomodulators (e.g., systemic steroids, interferons, or interleukins) or other chemotherapy.