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

NCT00002263 | Completed

• 2 other identifiers: 067B206
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; Cytopenias

Keywords

Pilot Projects; Neutropenia; Granulocyte-Macrophage Colony-Stimulating Factor; Acquired Immunodeficiency Syndrome; Zidovudine

Interventions

Zidovudine DRUG

Sargramostim DRUG

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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).

Sponsors & Collaborators

• Sandoz: lead

Study Sites (1)

Natl Cancer Institute / HIV / AIDS Malignancy Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

HIV Infections; Cytopenia; Neutropenia; Acquired Immunodeficiency Syndrome

Interventions

Zidovudine; sargramostim

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1990-01

Locations

US (1)