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

Sponsor

Sandoz (Industry)

Overall Status

Completed

CT.gov ID

NCT00002263

Collaborator

(none)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Cytopenias	Drug: Zidovudine Drug: Sargramostim	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.