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.
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
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
- Prior radiation therapy. Active substance abuse.