Search / Trial NCT00002263

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

Launched by SANDOZ · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

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

ClinConnect Summary

No description provided

Gender

ALL

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.

About Sandoz

Sandoz, a global leader in generic pharmaceuticals and biosimilars, is committed to advancing healthcare by providing high-quality, affordable medications that enhance patient access to essential treatments. As a division of Novartis, Sandoz leverages innovative research and development to deliver a diverse portfolio of products across various therapeutic areas, including oncology, immunology, and cardiovascular health. The company prioritizes rigorous clinical trials to ensure the safety and efficacy of its offerings, fostering collaboration with healthcare professionals and regulatory bodies to meet the evolving needs of patients worldwide. Through its dedication to quality and sustainability, Sandoz aims to improve health outcomes and contribute to more efficient healthcare systems globally.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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