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NCT00002263 · ClinicalTrials.gov registry record · NA

A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine

A NA study of HIV Infections and Cytopenias, sponsored by Sandoz.

Completed
Registry status
NA
Development phase
1
Study location

NCT00002263 is a NA study of HIV Infections and Cytopenias that has completed, run by Sandoz. The trial reports 1 study location across 1 state.

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The verdict

NCT00002263, a NA study of HIV Infections and Cytopenias, has completed, sponsored by Sandoz.

COMPLETED
Registry status
NA
Development phase
1
Study location

Study Summary

To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of concomitant GM-CSF on other hematologic parameters. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.

Interventions

  • DRUG Zidovudine
  • DRUG Sargramostim

Study Locations (1)

Maryland

  • Natl Cancer Institute / HIV / AIDS Malignancy Branch - Bethesda

Trial Details

FieldValue
Phase NA

Sponsor

Sandoz

29 total trials

What the Registry Record Tells You About NCT00002263

The ClinicalTrials.gov registry entry for NCT00002263 describes a study currently listed as completed, categorized as NA. 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.

NCT00002263 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00002263 about?

NCT00002263 is a clinical study titled "A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine". To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ...

What is the current status of trial NCT00002263?

This trial is currently completed. It is a NA study.

What conditions does trial NCT00002263 study?

This clinical trial studies the following conditions: HIV Infections, Cytopenias.

What interventions are being tested in trial NCT00002263?

The interventions under investigation include: Zidovudine (DRUG), Sargramostim (DRUG).

Who is sponsoring clinical trial NCT00002263?

This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00002263 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.