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Completed

NCT Number: NCT00002006

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

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Agranulocytosis Blood-Borne Infections Communicable Diseases Cytopenia Cytopenias Genital Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Leukocyte Disorders Leukopenia Neutropenia RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Natl Cancer Institute

Bethesda, Maryland, 20892, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zidovudine

Drug

Sargramostim

Drug

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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