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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Peginterferon alfa-2b

Criteria

Inclusion Criteria

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.)

Exclusion Criteria

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.