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A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex

Primary Purpose

HIV Infections, Cytopenias

Status
Completed
Phase
Not Applicable
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 Injections, Subcutaneous, Erythropoietin, 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 Treatment: Allowed: Radiation or laser therapy to Kaposi's sarcoma lesions provided the dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area. Patients must have: A diagnosis of AIDS or AIDS related complex (ARC) as defined by current CDC guidelines. Life expectancy > 6 months. Defined blood cell counts that may be achieved by transfusion. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: History of malignancy other than Kaposi's sarcoma (KS). Presence of > 50 cutaneous KS lesions or progression of KS over the previous 30 days. Presence of opportunistic infection requiring ongoing therapy with known bone marrow suppressive agents. History of cardiovascular disease. History of seizures. HIV related dementia or altered mental status that would prohibit the giving and understanding of informed consent. Presence of iron deficiency anemia as defined by serum ferritin < 30 ng or iron to TIBC ratio < 15 percent. A PT > 15 and a PTT > 40 unless due to a documented circulating lupus anticoagulant. Concurrent Medication: Excluded: Trimethoprim / sulfamethoxazole. Fansidar. Non-FDA approved antiretrovirals. Hyperimmunization with polio virus. Ribavirin. Isoprinosine. Dextran sulfate. Fu zheng herbs. AL 721 or its congeners. Imuthiol. Interferons. Chronic use of acyclovir (> 10 days out of 30 days). = or > 3g/day oral vitamin C. Patients with the following are excluded: Co-existing conditions and symptoms described in Patient Exclusion Co-existing Conditions. Prior Medication: Excluded within 2 weeks of study entry: Any non-FDA approved drug. Excluded within 4 weeks of study entry: Systemic cytotoxic chemotherapy for Kaposi's sarcoma. Investigational agents. Excluded: Colony stimulating factors. Prior Treatment: Excluded within 4 weeks of study entry: Radiation therapy for Kaposi's sarcoma exceeding 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area. Risk Behavior: Excluded within 3 months of study entry: Regular excessive use of alcohol, hallucinogens or other psychotropic agents which are possibly addicting.

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
NCT00002281
Brief Title
A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex
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 AIDS or ARC
Study Type
Interventional

2. Study Status

Record Verification Date
January 1990
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 (granulocyte colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe AIDS related complex (ARC). To evaluate the safety, tolerance, and biological activity of EPO given 3 times weekly by SC 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 3 dose levels of AZT given to patients with AIDS or severe ARC concomitantly treated with G-CSF and EPO. 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, Cytopenias
Keywords
Injections, Subcutaneous, Erythropoietin, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
24 (false)

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 Treatment: Allowed: Radiation or laser therapy to Kaposi's sarcoma lesions provided the dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area. Patients must have: A diagnosis of AIDS or AIDS related complex (ARC) as defined by current CDC guidelines. Life expectancy > 6 months. Defined blood cell counts that may be achieved by transfusion. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: History of malignancy other than Kaposi's sarcoma (KS). Presence of > 50 cutaneous KS lesions or progression of KS over the previous 30 days. Presence of opportunistic infection requiring ongoing therapy with known bone marrow suppressive agents. History of cardiovascular disease. History of seizures. HIV related dementia or altered mental status that would prohibit the giving and understanding of informed consent. Presence of iron deficiency anemia as defined by serum ferritin < 30 ng or iron to TIBC ratio < 15 percent. A PT > 15 and a PTT > 40 unless due to a documented circulating lupus anticoagulant. Concurrent Medication: Excluded: Trimethoprim / sulfamethoxazole. Fansidar. Non-FDA approved antiretrovirals. Hyperimmunization with polio virus. Ribavirin. Isoprinosine. Dextran sulfate. Fu zheng herbs. AL 721 or its congeners. Imuthiol. Interferons. Chronic use of acyclovir (> 10 days out of 30 days). = or > 3g/day oral vitamin C. Patients with the following are excluded: Co-existing conditions and symptoms described in Patient Exclusion Co-existing Conditions. Prior Medication: Excluded within 2 weeks of study entry: Any non-FDA approved drug. Excluded within 4 weeks of study entry: Systemic cytotoxic chemotherapy for Kaposi's sarcoma. Investigational agents. Excluded: Colony stimulating factors. Prior Treatment: Excluded within 4 weeks of study entry: Radiation therapy for Kaposi's sarcoma exceeding 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area. Risk Behavior: Excluded within 3 months of study entry: Regular excessive use of alcohol, hallucinogens or other psychotropic agents which are possibly addicting.
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.
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A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex

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