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

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Sandoz

Status

Completed

Conditions

Cytopenias
HIV Infections

Treatments

Drug: Sargramostim
Drug: Zidovudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002263
206
067B

Details and patient eligibility

About

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.

Sex

All

Ages

6 months to 12 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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