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NCT00002255 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
NCT00002255 is a Phase 1 study that has completed, run by Amgen.
The verdict
NCT00002255, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study 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.
Interventions
- DRUG Zidovudine
- DRUG Filgrastim
- DRUG Epoetin alfa
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002255
The ClinicalTrials.gov registry entry for NCT00002255 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Zidovudine is the first listed.
NCT00002255 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00002255 about?
NCT00002255 is a clinical study titled "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)". 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 saf...
What is the current status of trial NCT00002255?
This trial is currently completed. It is a Phase 1 study.
What interventions are being tested in trial NCT00002255?
The interventions under investigation include: Zidovudine (DRUG), Filgrastim (DRUG), Epoetin alfa (DRUG).
Who is sponsoring clinical trial NCT00002255?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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