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A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Sandoz Inc.
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002007
  Purpose

To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.


Condition Intervention
HIV Infections
Cytopenias
Drug: Zidovudine
Drug: Sargramostim

Study Type: Interventional
Study Design: Treatment, Dose Comparison
Official Title: A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia

Resource links provided by NLM:

  Eligibility

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

Inclusion Criteria

Patients must have:

  • Serum antibody to HIV with or without evidence of HIV antigenemia.
  • White blood cells (WBC) = or < 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week.
  • Qualifying indications for AZT therapy.
  • Life expectancy = or > 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Current or past history of malignancy including Kaposi's sarcoma.
  • Excessive diarrhea or significant malabsorption.
  • If patients have had > 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene < 75 IU/ml, serum vitamin A < 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria.
  • Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO).
  • Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
  • Active OI requiring systemic treatment.
  • Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Concurrent Medication:

Excluded within 4 weeks of study entry:

  • Zidovudine (AZT).
  • Other antiviral agent associated with leukopenia.
  • Investigational drug.
  • Immunomodulators.
  • Interferon.
  • Steroids.
  • Excluded within 8 weeks of study entry:
  • Ribavirin.
  • Excluded within 4 months of study entry:
  • Suramin.

Patients with the following are excluded:

  • Current or past history of malignancy including Kaposi's sarcoma.
  • Excessive diarrhea or significant malabsorption.
  • Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (OI).
  • Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
  • Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Prior Medication:

Excluded:

  • Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) that may cause leukopenia.

Risk Behavior:

Excluded:

  • Current drug or alcohol abusers.
  • Unprotected sexual contact or other activities that may result in reinfection with HIV.

Patients must be willing to refrain from unprotected sexual contact or other activities that may result in reinfection with HIV.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002007

Locations
United States, Maryland
Natl Cancer Institute
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Sandoz Inc.
  More Information

No publications provided

Study ID Numbers: 067C, 202
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002007     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Leukopenia
Granulocyte-Macrophage Colony-Stimulating Factor
Acquired Immunodeficiency Syndrome
Zidovudine

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Hematologic Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
Leukocyte Disorders
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Leukopenia
Retroviridae Infections

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 September 02, 2009