Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals
NCT ID: NCT00002087
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Alvircept sudotox
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Pharmacia and Upjohn
INDUSTRY
Locations
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Stanford Univ Med Ctr
Stanford, California, United States
Countries
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References
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Davey RT Jr, Boenning CM, Herpin BR, Batts DH, Metcalf JA, Wathen L, Cox SR, Polis MA, Kovacs JA, Falloon J, et al. Use of recombinant soluble CD4 Pseudomonas exotoxin, a novel immunotoxin, for treatment of persons infected with human immunodeficiency virus. J Infect Dis. 1994 Nov;170(5):1180-8. doi: 10.1093/infdis/170.5.1180.
Other Identifiers
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Amend 022
Identifier Type: -
Identifier Source: secondary_id
P/3325/0002
Identifier Type: -
Identifier Source: secondary_id
084A
Identifier Type: -
Identifier Source: org_study_id