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

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

This study has been completed.

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

MedlinePlus related topics:

AIDS

U.S. FDA Resources

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

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
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002087
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:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on December 03, 2008