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:	Treatment, Dose Comparison, Pharmacokinetics Study
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:

MedlinePlus related topics: AIDS

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

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

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.

Study ID Numbers:	067A, 07936
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002006 History of Changes
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:

Antimetabolites
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Leukocyte Disorders
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Hematologic Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Leukopenia

ClinicalTrials.gov processed this record on November 27, 2009