- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002281
A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex
June 23, 2005 updated by: Amgen
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA Med Ctr
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
January 1, 1990
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- AIDS-Related Complex
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Hematinics
- Epoetin Alfa
- Zidovudine
Other Study ID Numbers
- 061A
- GCSF-8808-109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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