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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alvircept sudotox
Sponsored by
Pharmacia and Upjohn
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Recombinant Proteins, Acquired Immunodeficiency Syndrome, Antigens, CD4, AIDS-Related Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Univ Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pharmacia and Upjohn
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1. Study Identification

Unique Protocol Identification Number
NCT00002087
Brief Title
Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals
Official Title
Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
April 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmacia and Upjohn

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Recombinant Proteins, Acquired Immunodeficiency Syndrome, Antigens, CD4, AIDS-Related Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Alvircept sudotox

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Stanford Univ Med Ctr
City
Stanford
State/Province
California
ZIP/Postal Code
943055107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7963711
Citation
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.
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Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals

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