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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

Primary Purpose

HIV Infections, Cytopenias

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interleukin-3
Sponsored by
Sandoz
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Interleukin-3, Recombinant Proteins, Leukopenia, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thrombocytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New England Deaconess Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Sandoz
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1. Study Identification

Unique Protocol Identification Number
NCT00002258
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 1992
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sandoz

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Cytopenias
Keywords
Interleukin-3, Recombinant Proteins, Leukopenia, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Interleukin-3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
New England Deaconess Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7576933
Citation
Scadden DT, Levine JD, Bresnahan J, Gere J, McGrath J, Wang Z, Resta DJ, Young D, Hammer SM. In vivo effects of interleukin 3 in HIV type 1-infected patients with cytopenia. AIDS Res Hum Retroviruses. 1995 Jun;11(6):731-40. doi: 10.1089/aid.1995.11.731.
Results Reference
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PubMed Identifier
11035615
Citation
Levine AM, Li P, Cheung T, Tulpule A, Von Roenn J, Nathwani BN, Ratner L. Chemotherapy consisting of doxorubicin, bleomycin, vinblastine, and dacarbazine with granulocyte-colony-stimulating factor in HIV-infected patients with newly diagnosed Hodgkin's disease: a prospective, multi-institutional AIDS clinical trials group study (ACTG 149). J Acquir Immune Defic Syndr. 2000 Aug 15;24(5):444-50. doi: 10.1097/00126334-200008150-00009.
Results Reference
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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

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