Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002087

Run by

Pharmacia and Upjohn

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford Univ Med Ctr — Stanford, California, United States

Full record on ClinicalTrials.gov

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