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NCT00006066 · ClinicalTrials.gov registry record · Phase 1

Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children With Weakened Immune Systems

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

Completed
Registry status
Phase 1
Development phase
92
Enrollment target
14
Study locations

NCT00006066 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 92 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (79% lower). The trial reports 14 study locations across 7 states.

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The verdict

NCT00006066, 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
92 participants
Enrollment target
14
Study locations

Study Summary

The purpose of this study is to determine the safety of a drug called interleukin-2 (IL-2) given with anti-HIV therapy in children with HIV infection. This study will also determine the best dose of IL-2 to give children. IL-2 is an important substance produced by the body's white blood cells that helps the body fight infection. People with HIV infection do not produce enough IL-2. It is hoped that IL-2 treatment will help boost the immune system in people with HIV infection. It has not been studied very much in children and doctors need to know what doses are safe to give.

Conditions Studied

Interventions

  • DRUG Aldesleukin
  • BIOLOGICAL Tetanus and Diphtheria Toxoids Adsorbed
  • BIOLOGICAL Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
  • BIOLOGICAL Diphtheria and Tetanus Toxoids Adsorbed
  • DRUG Bacteriophage phi X 174

Study Locations (14)

California

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp. - Long Beach
  • Usc La Nichd Crs - Los Angeles
  • UCSD Maternal, Child, and Adolescent HIV CRS - San Diego
  • UCSF Pediatric AIDS CRS - San Francisco

New York

  • Nyu Ny Nichd Crs - New York
  • Columbia IMPAACT CRS - New York
  • SUNY Upstate Med. Univ., Dept. of Peds. - Syracuse

District of Columbia

  • Children's National Med. Ctr. Washington DC NICHD CRS - Washington D.C.
  • Children's National Med. Ctr., ACTU - Washington D.C.

Florida

  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS - Miami
  • USF - Tampa NICHD CRS - Tampa

Louisiana

  • Tulane/LSU Maternal/Child CRS - New Orleans

Massachusetts

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

Other

  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS - San Juan

Trial Details

FieldValue
Enrollment Target 92 participants
Est. Completion 2006-06
Phase Phase 1

What the Registry Record Tells You About NCT00006066

The ClinicalTrials.gov registry entry for NCT00006066 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 92 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 (79% 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 5 interventions - of which Aldesleukin is the first listed.

NCT00006066 reports 14 study locations spanning 7 distinct geographic areas - top geographies include California, New York, District of Columbia.

Frequently Asked Questions

What is clinical trial NCT00006066 about?

NCT00006066 is a clinical study titled "Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children With Weakened Immune Systems". The purpose of this study is to determine the safety of a drug called interleukin-2 (IL-2) given with anti-HIV therapy in children with HIV infection. This study will also determine the best dose of IL-2 to give children. IL-2 is an important substance produced by the body's white blood cells that ...

What is the current status of trial NCT00006066?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 92 participants. Estimated completion is 2006-06.

What conditions does trial NCT00006066 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00006066?

The interventions under investigation include: Aldesleukin (DRUG), Tetanus and Diphtheria Toxoids Adsorbed (BIOLOGICAL), Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (BIOLOGICAL), Diphtheria and Tetanus Toxoids Adsorbed (BIOLOGICAL), Bacteriophage phi X 174 (DRUG).

Who is sponsoring clinical trial NCT00006066?

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 NCT00006066 being conducted?

This trial has 14 study locations across California, District of Columbia, Florida, Louisiana, Massachusetts. 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.