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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

This study has been completed.
Study NCT00002258.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  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
Official Title  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
Brief Summary

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.

Detailed Description
Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Open Label, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Cytopenias
Intervention  Drug: Interleukin-3
MEDLINE PMIDs 7576933,   11035615
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
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.

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002258
Organization ID 080A
Secondary IDs †† B104
Study Sponsor  Sandoz Inc.
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date November 1992
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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