search
Back to results

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

Primary Purpose

HIV Infections, Cytopenias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sargramostim
Sponsored by
Sandoz
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Pilot Projects, Neutropenia, Granulocyte-Macrophage Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept 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. 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.

Sites / Locations

  • Natl Cancer Institute / HIV / AIDS Malignancy Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Sandoz
search

1. Study Identification

Unique Protocol Identification Number
NCT00002263
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sandoz

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Cytopenias
Keywords
Pilot Projects, Neutropenia, Granulocyte-Macrophage Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Sargramostim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Natl Cancer Institute / HIV / AIDS Malignancy Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs