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A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002263
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of concomitant GM-CSF on other hematologic parameters. 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
HIV Infections Cytopenias Drug: Zidovudine Drug: Sargramostim

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine

Resource links provided by NLM:


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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Zidovudine (AZT) on NIAID 86-C-175.

Patients must have:

  • Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex.
  • Granulocytopenia (< or = to 800 cells/mm3) associated with the administration of AZT on protocol NIAID 86-C-175.
  • Life expectancy > 3 months.
  • Functioning indwelling central venous access device in place.

Prior Medication:

Allowed within 48 hours of study entry:

  • Prophylactic antibiotics.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Critically ill or clinically unstable.
  • Significant, active opportunistic or other infection requiring specific drug therapy at time of study entry.
  • Ongoing IV alimentation.
  • Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia.
  • Past history of or current evidence for any chronic hematologic disorder other than hemophilia A or B, anemia of chronic disease or anemia related to HIV infection.
  • Malignancy likely to require systemic treatment during study.

Patients with the following are excluded:

  • Critically ill, clinically unstable, or with concomitant diseases listed in Patient Exclusion Co-existing Conditions.
  • Hypersensitivity to zidovudine (AZT) or any other nucleoside analog.

Prior Medication:

Excluded within 48 hours of study entry:

  • Antibiotics.
  • Excluded within 30 days of study entry:
  • Antiretroviral agents other than zidovudine (AZT).
  • Acyclovir.
  • Ganciclovir.
  • Any investigational drug.
  • Immunomodulating drugs.
  • Cytolytic chemotherapeutic agents.
  • Corticosteroids.
  • Immunoglobulin preparations.
  • Excluded within 4 months of study entry:
  • Suramin.

Prior Treatment:

Excluded within 6 months of study entry:

  • Bone marrow transplantation.
  • Excluded within 4 weeks of study entry:
  • Lymphocyte transfusions.
  • Radiation therapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002263


Locations
United States, Maryland
Natl Cancer Institute / HIV / AIDS Malignancy Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Sandoz
  More Information

ClinicalTrials.gov Identifier: NCT00002263     History of Changes
Other Study ID Numbers: 067B
206
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
Last Verified: January 1990

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

Additional relevant MeSH terms:
HIV Infections
Neutropenia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Zidovudine
Molgramostim
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antineoplastic Agents