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| Sponsored by: |
Amgen |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002281 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections Cytopenias |
Drug: Filgrastim Drug: Epoetin alfa Drug: Zidovudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Treatment:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 2 weeks of study entry:
Prior Treatment:
Excluded within 4 weeks of study entry:
Risk Behavior:
Excluded within 3 months of study entry:
Contacts and Locations
More Information
| Study ID Numbers: | 061A, GCSF-8808-109 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002281 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Injections, Subcutaneous Erythropoietin Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
|
Epoetin Alfa Antimetabolites Sexually Transmitted Diseases, Viral Anti-HIV Agents Hematinics Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex |
Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Epoetin Alfa Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Hematologic Agents Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Hematinics Acquired Immunodeficiency Syndrome AIDS-Related Complex Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |