Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
NCT ID: NCT00006325
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2004-03-31
Brief Summary
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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.)
Detailed Description
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In a dose-escalation study, patients add weekly PEG-Intron to their antiretroviral therapy for up to 6 weeks. The first 2 doses are received in the clinic where parents/guardians are trained to administer injections, and succeeding doses are given at home.
Patients are enrolled from 2 cohorts. An older cohort of ages 2 to 16 years receives PEG-Intron at the lowest drug level. If the dose is tolerated, patients are added and if safety criteria are met, patients are enrolled in the next higher dose level. The dose level will be increased similarly for up to 4 doses. An optimal dose level is chosen.
Cohort II patients are a younger group ranging from 3 months to under 2 years of age. Patients initially receive the next lower PEG-Intron dose to the optimal dose identified in Cohort I \[AS PER AMENDMENT 07/23/01: or 1 microg/kg if the optimal dose proves to be 1 microg/kg\]. If this dose is safely tolerated, additional patients are added. If this dose level meets safety criteria, patients are enrolled to receive the optimal dose level. Patients are evaluated with the same safety criteria as Cohort I. Patients in both cohorts who have at least a 0.5 log reduction in HIV RNA at 28 days of treatment are offered continued treatment for a total of 60 weeks.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Peginterferon alfa-2b
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Months
16 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Katherine Luzuriaga
Role: STUDY_CHAIR
Andrea Kovacs
Role: STUDY_CHAIR
Locations
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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
Countries
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Other Identifiers
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PACTG P1017
Identifier Type: -
Identifier Source: secondary_id
ACTG P1017
Identifier Type: -
Identifier Source: secondary_id
11652
Identifier Type: REGISTRY
Identifier Source: secondary_id
P1017
Identifier Type: -
Identifier Source: org_study_id