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NCT00000626 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
27
Enrollment target

NCT00000626 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 27 participants.

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The verdict

NCT00000626, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
27 participants
Enrollment target

Study Summary

Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in reducing tumor burden in HIV-infected patients with Hodgkin's disease. Secondary: To determine the durability of tumor response to ABVD plus G-CSF over the 2-year study period; to observe the incidence of bacterial and opportunistic infections in HIV-infected patients with Hodgkin's disease receiving this regimen; to document quality of life of patients receiving this regimen. Addition of granulocyte colony-stimulating factor may prevent neutropenia caused by chemotherapy, allowing more timely administration of chemotherapy and improved response.

Interventions

  • DRUG Dacarbazine
  • DRUG Filgrastim
  • DRUG Doxorubicin hydrochloride
  • DRUG Bleomycin sulfate
  • DRUG Vinblastine sulfate

Trial Details

FieldValue
Enrollment Target 27 participants
Est. Completion 1999-02
Phase Phase 2

What the Registry Record Tells You About NCT00000626

The ClinicalTrials.gov registry entry for NCT00000626 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Dacarbazine is the first listed.

NCT00000626 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000626 about?

NCT00000626 is a clinical study titled "Phase II Study of Filgrastim (G-CSF) Plus ABVD in the Treatment of HIV-Associated Hodgkin's Disease". Primary: To assess the toxicity of chemotherapy with ABVD (doxorubicin / bleomycin / vinblastine / dacarbazine) when given with filgrastim ( granulocyte colony-stimulating factor; G-CSF ) in patients with underlying HIV infection and Hodgkin's disease; to observe the efficacy of ABVD and G-CSF in re...

What is the current status of trial NCT00000626?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. Estimated completion is 1999-02.

What interventions are being tested in trial NCT00000626?

The interventions under investigation include: Dacarbazine (DRUG), Filgrastim (DRUG), Doxorubicin hydrochloride (DRUG), Bleomycin sulfate (DRUG), Vinblastine sulfate (DRUG).

Who is sponsoring clinical trial NCT00000626?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.