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NCT00000849 · ClinicalTrials.gov registry record · Phase 1

A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children

A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
27
Enrollment target
14
Study locations

NCT00000849 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 27 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The trial reports 14 study locations across 10 states.

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The verdict

NCT00000849, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target
14
Study locations

Study Summary

The purpose of this study is to determine the safety and maximum tolerated dose (the highest dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children. This study also evaluates the effect of rIL-2 on the immune system of these patients. IL-2 is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. HIV-infected patients do not produce enough IL-2, and it is hoped that the use of rIL-2 may improve immune system function in these patients. First, it is necessary to determine the safety and effectiveness of this drug in HIV-infected children.

Conditions Studied

HIV Infections

Interventions

  • DRUG Aldesleukin

Study Locations (14)

New York

  • NYU Med. Ctr., Dept. of Medicine - New York
  • Columbia IMPAACT CRS - New York
  • Incarnation Children's Ctr. - New York

California

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp. - Long Beach
  • UCSF Pediatric AIDS CRS - San Francisco

Illinois

  • Chicago Children's CRS - Chicago
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease - Chicago

Colorado

  • Univ. of Colorado Denver NICHD CRS - Aurora

Florida

  • Univ. of Florida Jacksonville NICHD CRS - Jacksonville

Louisiana

  • Tulane/LSU Maternal/Child CRS - New Orleans

Massachusetts

  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases - Boston

Pennsylvania

  • The Children's Hosp. of Philadelphia IMPAACT CRS - Philadelphia

Trial Details

FieldValue
Enrollment Target 27 participants
Est. Completion 2001-03
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00000849

The ClinicalTrials.gov registry entry for NCT00000849 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). 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 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Aldesleukin is the first listed.

NCT00000849 reports 14 study locations spanning 10 distinct geographic areas - top geographies include New York, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT00000849 about?

NCT00000849 is a clinical study titled "A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children". The purpose of this study is to determine the safety and maximum tolerated dose (the highest dose that can be given safely) of recombinant Interleukin-2 (rIL-2) in HIV-infected children. This study also evaluates the effect of rIL-2 on the immune system of these patients. IL-2 is a substance natura...

What is the current status of trial NCT00000849?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. Estimated completion is 2001-03.

What conditions does trial NCT00000849 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000849?

The interventions under investigation include: Aldesleukin (DRUG).

Who is sponsoring clinical trial NCT00000849?

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

Where is trial NCT00000849 being conducted?

This trial has 14 study locations across California, Colorado, Florida, Illinois, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.