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An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Filgrastim
Epoetin alfa
Zidovudine
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Erythropoietin, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Ganciclovir (DHPG) for treatment of CMV infections. Concurrent Treatment: Allowed: Radiotherapy or laser therapy for Kaposi's sarcoma lesions provided dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm total body surface area. Patients must have: AIDS or severe ARC. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Opportunistic infection requiring ongoing therapy with known bone marrow-suppressive agents. (Exception: patients may take ganciclovir for treatment of CMV infections.) Evidence of a primary hematologic or infectious disorder unrelated to infection with the HIV virus. HIV-related dementia or altered mental status that would prohibit informed consent. More than 50 cutaneous Kaposi's sarcoma lesions or progression of Kaposi's sarcoma during the previous 30 days. Uncontrolled hypertension (defined as diastolic greater than 100 mm Hg). Presence of iron deficiency anemia as defined by serum ferritin less than 30 ng or iron TIBC ration less than 15 percent. Concurrent Medication: Excluded: Known bone marrow-suppressive agents such as trimethoprim / sulfamethoxazole or Fansidar for PCP prophylaxis. Any other non-FDA approved agent that may have antiretroviral activity. Hyperimmunization with polio virus, ribavirin, isoprinosine, dextran sulfate, fu zheng herbs, AL 721 or its congeners, imuthiol, interferons, chronic (> 10 days out of 30 days) use of Zovirax (acyclovir), and/or > 3 g/day oral vitamin C. Patients with the following prior conditions are excluded: History of malignancy other than Kaposi's sarcoma. History of cardiovascular disease or seizures. Prior Medication: Excluded: Systemic cytotoxic chemotherapy within the previous 4 weeks for Kaposi's sarcoma. Investigational drugs within the previous 4 weeks. Prior colony stimulating factor (CSF). Any non-FDA approved drug within the previous 2 weeks. Prior Treatment: Excluded: Radiotherapy within the previous 4 weeks for Kaposi's sarcoma. Regular excessive use, currently or within the previous 3 months, of alcohol or hallucinogens or other psychotropic agents that are possibly addictive.

Sites / Locations

  • UCLA Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

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

Unique Protocol Identification Number
NCT00002255
Brief Title
An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)
Official Title
An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 1991
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
Amgen

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety, tolerance, and biological activity of filgrastim (recombinant granulocyte colony stimulating factor; G-CSF) given by daily subcutaneous injection prior to and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe ARC. To evaluate the safety, tolerance, and biological activity of recombinant EPO given three times weekly by subcutaneous injection concomitantly with G-CSF and prior to and concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and tolerance of three dose levels of AZT given concomitantly with G-CSF and EPO in patients with AIDS or severe ARC. To study the effects of G-CSF on neutrophil function and number in patients with AIDS or severe ARC. To study the effect of G-CSF alone and in combination with EPO on HIV replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia, and semiquantitative HIV cocultures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Erythropoietin, Granulocyte Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine

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)
Filgrastim
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Ganciclovir (DHPG) for treatment of CMV infections. Concurrent Treatment: Allowed: Radiotherapy or laser therapy for Kaposi's sarcoma lesions provided dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm total body surface area. Patients must have: AIDS or severe ARC. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Opportunistic infection requiring ongoing therapy with known bone marrow-suppressive agents. (Exception: patients may take ganciclovir for treatment of CMV infections.) Evidence of a primary hematologic or infectious disorder unrelated to infection with the HIV virus. HIV-related dementia or altered mental status that would prohibit informed consent. More than 50 cutaneous Kaposi's sarcoma lesions or progression of Kaposi's sarcoma during the previous 30 days. Uncontrolled hypertension (defined as diastolic greater than 100 mm Hg). Presence of iron deficiency anemia as defined by serum ferritin less than 30 ng or iron TIBC ration less than 15 percent. Concurrent Medication: Excluded: Known bone marrow-suppressive agents such as trimethoprim / sulfamethoxazole or Fansidar for PCP prophylaxis. Any other non-FDA approved agent that may have antiretroviral activity. Hyperimmunization with polio virus, ribavirin, isoprinosine, dextran sulfate, fu zheng herbs, AL 721 or its congeners, imuthiol, interferons, chronic (> 10 days out of 30 days) use of Zovirax (acyclovir), and/or > 3 g/day oral vitamin C. Patients with the following prior conditions are excluded: History of malignancy other than Kaposi's sarcoma. History of cardiovascular disease or seizures. Prior Medication: Excluded: Systemic cytotoxic chemotherapy within the previous 4 weeks for Kaposi's sarcoma. Investigational drugs within the previous 4 weeks. Prior colony stimulating factor (CSF). Any non-FDA approved drug within the previous 2 weeks. Prior Treatment: Excluded: Radiotherapy within the previous 4 weeks for Kaposi's sarcoma. Regular excessive use, currently or within the previous 3 months, of alcohol or hallucinogens or other psychotropic agents that are possibly addictive.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miles SA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Slamon D
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1709368
Citation
Miles SA, Mitsuyasu RT, Moreno J, Baldwin G, Alton NK, Souza L, Glaspy JA. Combined therapy with recombinant granulocyte colony-stimulating factor and erythropoietin decreases hematologic toxicity from zidovudine. Blood. 1991 May 15;77(10):2109-17.
Results Reference
background

Learn more about this trial

An Open-Label Phase I/II Study of Recombinant Granulocyte Colony Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)

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