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Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children

NCT00006325 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-11-01

No results posted yet for this study

Summary

The purpose of this study is to see if PEG-Intron is safe and tolerated when given to children, to see how much gets into the blood and how long it stays in the blood, and to see how well it works to reduce viral load (level of HIV in the blood).

PEG-Intron is an experimental drug that works differently than other anti-HIV medications. It decreases the ability of HIV to infect the T cells (a special type of cell that helps fight infection). PEG-Intron has been approved by the Food and Drug Administration (FDA) to treat hepatitis C in adults, but in this study, it is being used as an investigational agent for the treatment of HIV/AIDS. It has not been tested in children before and experience with PEG-Intron in adults is limited. (This protocol has been changed to reflect FDA approval of PEG-Intron for treating hepatitic C in adults.)

Conditions

  • HIV Infections

Interventions

DRUG

Peginterferon alfa-2b

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Katherine Luzuriaga

  • Andrea Kovacs

Study Design

Purpose
TREATMENT

Eligibility

Min Age
3 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2004-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006325 on ClinicalTrials.gov