Clinical Trials


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

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

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

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: October 2, 2000
Last updated: May 18, 2012
Last Verified: May 2012
History of Changes


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.)

Condition Intervention Phase
HIV Infections

Drug : Peginterferon alfa-2b
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of PEG-Intron in HIV-1 Infected Children

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 54
Study Completion Date: March 2004

Detailed Description:

The current optimal clinical management of HIV infection involves therapy with combinations of nucleoside and nonnucleoside reverse transcriptase inhibitors and HIV protease inhibitors. These regimens, though effective, do not completely eliminate HIV and the development of drug resistance is a major clinical problem. Interferons have been proposed as a possible treatment of HIV. Interferon-alfa inhibits HIV replication in vitro, and HIV-infected patients appear to have reduced production of interferons. Previous short-term clinical studies in adults showed anti-HIV activity, although there were safety and tolerability problems associated with the higher dose regimens used. This study will utilize a rising multiple-dose design to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of PEG-Intron in HIV-infected children.
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.



Ages Eligible for Study: 3 Months to 16 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00006325


United States, California
Long Beach Memorial (Pediatric)
Long Beach, California, United States, 90801
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, United States, 900276016
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
United States, Connecticut
Connecticut Children's Med Ctr
Farmington, Connecticut, United States, 060303805
United States, Florida
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
United States, New York
Schneider Children's Hosp
New Hyde Park, New York, United States, 11040
Harlem Hosp Ctr
New York, New York, United States, 10037
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
United States, Texas
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


Study Chair: Katherine Luzuriaga
Study Chair: Andrea Kovacs
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00006325   History of Changes  
Other Study ID Numbers: P1017  
  PACTG P1017  
  ACTG P1017  
Study First Received: October 2, 2000  
Last Updated: May 18, 2012  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Polyethylene Glycols
Interferon Alfa-2b
Dose-Response Relationship, Drug
Drug Therapy, Combination
Virus Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Peginterferon alfa-2b processed this data on July 08, 2020
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