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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
This study has been completed.
Sponsored by: 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

MedlinePlus related topics: AIDS
Drug Information available for: Zidovudine Sargramostim Granulocyte-macrophage colony-stimulating factor
U.S. FDA Resources
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
  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:
Study ID Numbers: 067A, 07936
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002006  
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

Study placed in the following topic categories:
Virus Diseases
Neutropenia
Sexually Transmitted Diseases, Viral
Hematologic Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
Leukocyte Disorders
Leukopenia
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009