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

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.