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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Pharmacia and Upjohn
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002087

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Alvircept sudotox	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Pharmacokinetics Study
Official Title:	Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Alvircept sudotox

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002087

Locations

United States, California
Stanford Univ Med Ctr
Stanford, California, United States, 943055107

Sponsors and Collaborators

Pharmacia and Upjohn

More Information

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.

Study ID Numbers:	084A, Amend 022, P/3325/0002
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002087 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Recombinant Proteins
Acquired Immunodeficiency Syndrome
Antigens, CD4
AIDS-Related Complex

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 02, 2009