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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00006325 |
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 |
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HIV Infections |
Drug: Peginterferon alfa-2b |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
Official Title: | Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of PEG-Intron in HIV-1 Infected Children |
Estimated Enrollment: | 54 |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |
UCSF / Moffitt Hosp - Pediatric | |
San Francisco, California, United States, 941430105 | |
Children's Hosp of Los Angeles/UCLA Med Ctr | |
Los Angeles, California, United States, 900276016 | |
Long Beach Memorial (Pediatric) | |
Long Beach, California, United States, 90801 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
United States, Connecticut | |
Connecticut Children's Med Ctr | |
Farmington, Connecticut, United States, 060303805 | |
United States, Florida | |
Univ of Miami (Pediatric) | |
Miami, Florida, United States, 33161 | |
Univ of Florida Health Science Ctr / Pediatrics | |
Jacksonville, Florida, United States, 32209 | |
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 | |
Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
Schneider Children's Hosp | |
New Hyde Park, New York, United States, 11040 | |
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 |
Study Chair: | Katherine Luzuriaga | |
Study Chair: | Andrea Kovacs |
Study ID Numbers: | ACTG P1017, PACTG P1017 |
Study First Received: | October 2, 2000 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00006325 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Polyethylene Glycols Interferon Alfa-2b HIV-1 Dose-Response Relationship, Drug |
Drug Therapy, Combination Virus Inhibitors Anti-HIV Agents Pharmacokinetics |
Interferon-alpha Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Interferons Antiviral Agents Immunologic Deficiency Syndromes Virus Diseases |
HIV Seropositivity HIV Infections Sexually Transmitted Diseases Peginterferon alfa-2b Interferon Alfa-2a Retroviridae Infections Interferon Alfa-2b |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Peginterferon alfa-2b Retroviridae Infections |