HIV Infections
Conditions
Keywords
Recombinant Proteins, Acquired Immunodeficiency Syndrome, Antigens, CD4, AIDS-Related Complex
Brief summary
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.
Interventions
Sponsors
Pharmacia and Upjohn
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Co-existing Condition: 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. Prior Medication: Excluded: * 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. Prior Treatment: Excluded: * Prior radiation therapy. Active substance abuse.
Countries
United States
Outcome results
None listed