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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Conditions Studied

HIV Infections Cytopenias

Interventions

  • DRUG Zidovudine
  • DRUG Sargramostim

Study Locations (1)

Maryland

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

Trial Details

FieldValue
Phase NA
Sandoz

29 total trials

What the finished NCT00002263 record still lists

NCT00002263 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

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 a single indexed study location in 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.

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Related registry views

Source: ClinicalTrials.gov NCT00002263, the US trial registry maintained by the National Library of Medicine. NCT00002263 (unsized enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.