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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Cytopenias
Drug: Interleukin-3
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002258

Locations
United States, Massachusetts
New England Deaconess Hosp
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Sandoz Inc.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002258     History of Changes
Other Study ID Numbers: 080A, B104
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Interleukin-3
Recombinant Proteins
Leukopenia
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Thrombocytopenia

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014