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Completed

NCT Number: NCT00002263

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

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.

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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

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Natl Cancer Institute / HIV / AIDS Malignancy Branch

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 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.

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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