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Stanford, California 94305


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.


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.



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Stanford, California 94305
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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