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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002258
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1992

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002258 on ClinicalTrials.gov Archive Site
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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
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

To determine the safety, tolerability and maximum tolerated dose of SDZ ILE 964 administered by daily subcutaneous injections in patients infected with human immunodeficiency virus (HIV) who have cytopenias (low blood cell counts). To obtain information about the biologic effects of SDZ ILE 964 administration in improving blood counts in HIV-infected patients. To obtain information about the effects of SDZ ILE-964 administration on both parameters of HIV replication and on residual immunologic function.

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Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Cytopenias
Drug: Interleukin-3
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002258
080A, B104
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Sandoz Inc.
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NIH AIDS Clinical Trials Information Service
November 1992

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP