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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002263
• Other study ID #: 067B
• Secondary ID: 206
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytopenias
• HIV Infections
• Neutropenia

Intervention

Drug:
• Zidovudine

• Sargramostim

Locations

Country	Name	City	State
United States	Natl Cancer Institute / HIV / AIDS Malignancy Branch	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz Inc.

Country where clinical trial is conducted

United States,