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NCT00002006 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility
A Phase 1 study of HIV Infections and Cytopenias, sponsored by Sandoz.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Study location
NCT00002006 is a Phase 1 study of HIV Infections and Cytopenias that has completed, run by Sandoz. The trial reports 1 study location across 1 state.
The verdict
NCT00002006, a Phase 1 study of HIV Infections and Cytopenias, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1
- Study location
Study Summary
To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Sargramostim
Study Locations (1)
Maryland
- Natl Cancer Institute - Bethesda
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002006
The ClinicalTrials.gov registry entry for NCT00002006 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 Sandoz, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Zidovudine is the first listed.
NCT00002006 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00002006 about?
NCT00002006 is a clinical study titled "A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility". To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidov...
What is the current status of trial NCT00002006?
This trial is currently completed. It is a Phase 1 study.
What conditions does trial NCT00002006 study?
This clinical trial studies the following conditions: HIV Infections, Cytopenias.
What interventions are being tested in trial NCT00002006?
The interventions under investigation include: Zidovudine (DRUG), Sargramostim (DRUG).
Who is sponsoring clinical trial NCT00002006?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00002006 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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