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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.)

Key facts

Study ID

NCT00006325

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

54

Expected to finish

2004-03-01

Last updated by the study team

2021-11-01

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for this study if they:
• Are HIV-infected infants and children aged 3 months to 16 years.
• Have been on stable anti-HIV drugs for at least 16 weeks if over 6 months of age. Infants aged 3 to 6 months must be on stable anti-HIV drugs for at least 6 weeks. Children should be receiving at least 3 anti-HIV drugs.
• Have a viral load of more than 5,000 copies/ml.
• Have written informed consent from parent or guardian and, if able, can give written consent themselves.
• Are able to follow the schedule in the protocol.
• Have a parent/guardian who is willing to comply with study requirements.
• (This study has been changed to allow any combination of 3 anti-HIV drugs and to remove CD4 requirements.)

You may not qualify if…

• Patients will not be eligible for this study if they:
• Are breast-feeding or pregnant or not using birth control, if a female.
• Have abnormal thyroid activity.
• Have severe HIV symptoms.
• Have opportunistic (AIDS-related) infections or history of such infections within the preceding 2 months.
• Have participated in a clinical trial of an experimental drug in the previous month.
• Have a positive test result for hepatitis B or C.
• Have an allergy to E. coli.
• Have a mental disorder.
• Have a history of drug dependence and measure positive when screened.

Where it is running

• Long Beach Memorial (Pediatric) — Long Beach, California, United States
• Children's Hosp of Los Angeles/UCLA Med Ctr — Los Angeles, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Connecticut Children's Med Ctr — Farmington, Connecticut, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Univ of Massachusetts Med School — Worcester, Massachusetts, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• Schneider Children's Hosp — New Hyde Park, New York, United States
• Harlem Hosp Ctr — New York, New York, United States
• SUNY Health Sciences Ctr at Syracuse / Pediatrics — Syracuse, New York, United States
• Texas Children's Hosp / Baylor Univ — Houston, Texas, United States

Full record on ClinicalTrials.gov

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