Search / Trial NCT00002258

A Phase I, Open Label Trial to Evaluate the Safety, Tolerance and Biological Effects of SDZ ILE-964 (Recombinant Human Interleukin-3, RhIL-3) in HIV Infected Patients With Cytopenia

Launched by SANDOZ · Aug 30, 2001

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Trial Information

Current as of December 26, 2024

Completed

Keywords

Interleukin 3 Recombinant Proteins Leukopenia Acquired Immunodeficiency Syndrome Aids Related Complex Thrombocytopenia

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Patients must have:
  • • HIV seropositivity by Western blot.
  • • Advanced ARC or AIDS as defined by CDC.
  • • Cytopenia defined as total peripheral leukocyte count of \< 3,000 cells/mm3 or platelet count of \< 100,000 cells/mm3 or serum hemoglobin \< 10 g/dl.
  • • Anticipated life expectancy = or \> 6 months.
  • • Ambulatory.
  • • Willing to sign informed consent.
  • • Willing to forego use of any other investigational therapies except ddI.
  • Prior Medication:
  • Allowed \> 2 weeks prior to study entry:
  • • zidovudine.
  • * Allowed \> 4 weeks prior to study entry:
  • • systemic cytotoxic chemotherapy; investigational drugs; medications known to be myelosuppressive as ganciclovir, trimethoprim/sulfamethoxazole or dapsone.
  • * Allowed \> 6 weeks prior to study entry:
  • • other hemopoietic growth factor treatment as GM-CSF, EPO.
  • • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • • Active opportunistic infection.
  • • Symptoms of CNS disease referable to HIV infection.
  • • Dementia or altered mental status that would prohibit giving and understanding informed consent.
  • • Systemic chemotherapy.
  • • Investigational therapies other than ddI.
  • • Medications with known myelosuppressive effects such as ganciclovir, trimethoprim/sulfamethoxazole or dapsone or AZT.
  • • Other hematopoietic growth factor treatments as GM-CSF, G-CSF, or EPO.
  • • Prophylactic therapy for pneumocystis or oral thrush.
  • • ddI.
  • • Corticosteroids or topical corticosteroid creams.
  • Patients may not have:
  • • Life expectancy \< 6 months.
  • • Active drug or alcohol abuse.
  • • Active opportunistic infections.
  • • Treatment with any other investigational drugs except ddI within 4 weeks of study entry.
  • • Dementia or altered mental state that prohibits giving informed consent.
  • • Symptoms of CNS disease referable to HIV infection.
  • • Major surgery within 4 weeks of study entry.
  • • History of major pulmonary or cardiac disease.
  • • History of any prior malignancy other than Kaposi's sarcoma or noninvasive subcutaneous carcinoma.
  • • Documented allergic disorder such as asthma, history of anaphylaxis, atopy, serum sickness, or bronchospasm.
  • Not allowed within 2 weeks prior to study entry:
  • • zidovudine (AZT).
  • * Not allowed within 4 weeks prior to study entry:
  • • systemic cytotoxic chemotherapy; investigational drugs other than ddI; medications known to be myelosuppressive as ganciclovir, trimethoprim/sulfamethoxazole or dapsone.
  • * Not allowed within 6 weeks prior to study entry:
  • • other hematopoietic growth factor treatment as GM-CSC, G-CSF, EPO.
  • • Radiation therapy or major surgery within 4 weeks of study entry.
  • • Active drug or alcohol abuse.

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

Boston, Massachusetts, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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