A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility - Full Text View

Sponsor:	Sandoz Inc.
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002006

Purpose

To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.

Condition	Intervention	Phase
HIV Infections Cytopenias	Drug: Zidovudine Drug: Sargramostim	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment
Official Title:	A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency cyclic neutropenia

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

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

Criteria

Inclusion Criteria

Concurrent Treatment:

Allowed:

Minimal local irradiation for tumors.

Patients must have:

Diagnosis of AIDS or AIDS related complex (ARC).
Neutropenia, due either to zidovudine (AZT) or HIV infection.
Life expectancy = or > 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following:
Serum carotene less than 75 IU/ml.
Vitamin A level less than 75 IU/ml.
More than 4 foul-smelling or greasy stools per day.
Other criteria of malabsorption.
Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation.
Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection.

Concurrent Medication:

Excluded within 4 weeks of study entry:

Any investigational drug.
Immunomodulating agents.
Hormonal therapy.
Cytolytic chemotherapeutic agents.
Antiretroviral agent other than zidovudine (AZT).
Excluded within 4 months of study entry:
Suramin.
Excluded within 3 months of study entry:
Ribavirin.

Patients with the following are excluded:

Significant malabsorption.
Tumor likely to require specific antitumor therapy during study.
Other significant medical problems and conditions specified in Patient Exclusion Co-Existing Conditions.
Uncorrected nutritional deficiencies that may contribute to neutropenia.
Hypersensitivity to zidovudine (AZT) or other nucleoside analogs.
Profound dementia or altered mental status that would prohibit the giving of informed consent.

Prior Treatment:

Excluded within 1 month of study entry:

Transfusion.
Excluded within 4 weeks of study entry:
Radiation therapy to greater than 100 cm2 body area.

Current drug or alcohol abuse. Unprotected sexual behavior or other activities which might introduce a new inoculation of HIV during the study.

Patients must be willing to refrain from unprotected sexual or other activities which might introduce a new inoculum of HIV during the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002006

Locations

United States, Maryland
Natl Cancer Institute
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Sandoz Inc.

More Information

Publications:

Levine JD, Allan JD, Tessitore JH, Falcone N, Galasso F, Israel RJ, Groopman JE. Recombinant human granulocyte-macrophage colony-stimulating factor ameliorates zidovudine-induced neutropenia in patients with acquired immunodeficiency syndrome (AIDS)/AIDS-related complex. Blood. 1991 Dec 15;78(12):3148-54.

ClinicalTrials.gov Identifier:	NCT00002006 History of Changes
Other Study ID Numbers:	067A, 07936
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Neutropenia
Drug Interactions
Granulocyte-Macrophage Colony-Stimulating Factor
Acquired Immunodeficiency Syndrome
Zidovudine

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Leukopenia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Leukocyte Disorders

Hematologic Diseases
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012