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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002087 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals
Official Title ^ICMJE	Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals
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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Alvircept sudotox
Study Arms / Comparison Groups
Publications *	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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002087
Responsible Party
Study ID Numbers ^ICMJE	084A, Amend 022, P/3325/0002
Study Sponsor ^ICMJE	Pharmacia and Upjohn
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	April 1994
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP