Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
Status:
Completed
Trial end date:
2004-03-01
Target enrollment:
Participant gender:
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.)
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)