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
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1990
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.
||Primary Purpose: Treatment
||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
|Ages Eligible for Study:
||6 Months to 12 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Allowed within 48 hours of study entry:
- Prophylactic antibiotics.
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.
Excluded within 48 hours of study entry:
- Excluded within 30 days of study entry:
- Antiretroviral agents other than zidovudine (AZT).
- Any investigational drug.
- Immunomodulating drugs.
- Cytolytic chemotherapeutic agents.
- Immunoglobulin preparations.
- Excluded within 4 months of study entry:
Excluded within 6 months of study entry:
- Bone marrow transplantation.
- Excluded within 4 weeks of study entry:
- Lymphocyte transfusions.
- Radiation therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002263
|Natl Cancer Institute / HIV / AIDS Malignancy Branch
|Bethesda, Maryland, United States, 20892 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Granulocyte-Macrophage Colony-Stimulating Factor
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors