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NCT00002070 · ClinicalTrials.gov registry record · Phase 3
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
A Phase 3 study, sponsored by Schering-Plough.
- Completed
- Registry status
- Phase 3
- Development phase
NCT00002070 is a Phase 3 study that has completed, run by Schering-Plough.
The verdict
NCT00002070, a Phase 3 study, has completed, sponsored by Schering-Plough.
- COMPLETED
- Registry status
- Phase 3
- Development phase
Study Summary
To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF.
Interventions
- DRUG Sargramostim
- DRUG Ganciclovir
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00002070
The ClinicalTrials.gov registry entry for NCT00002070 describes a study currently listed as completed, categorized as Phase 3. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Schering-Plough, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sargramostim is the first listed.
NCT00002070 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00002070 about?
NCT00002070 is a clinical study titled "Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis". To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved toleranc...
What is the current status of trial NCT00002070?
This trial is currently completed. It is a Phase 3 study.
What interventions are being tested in trial NCT00002070?
The interventions under investigation include: Sargramostim (DRUG), Ganciclovir (DRUG).
Who is sponsoring clinical trial NCT00002070?
This trial is sponsored by Schering-Plough, which has 4 total clinical trials registered on ClinicalTrials.gov.
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