- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00006325
Safety, Tolerability, and Anti-HIV Activity of PEG-Intron in HIV-Positive Children
Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of PEG-Intron in HIV-1 Infected Children
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.)
Přehled studie
Detailní popis
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.
Typ studie
Zápis
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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California
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Long Beach, California, Spojené státy, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, Spojené státy, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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Los Angeles, California, Spojené státy, 90033
- Los Angeles County - USC Med Ctr
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San Francisco, California, Spojené státy, 941430105
- UCSF / Moffitt Hosp - Pediatric
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Connecticut
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Farmington, Connecticut, Spojené státy, 060303805
- Connecticut Children's Med Ctr
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Florida
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Jacksonville, Florida, Spojené státy, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, Spojené státy, 33161
- Univ of Miami (Pediatric)
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Massachusetts
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Boston, Massachusetts, Spojené státy, 021155724
- Children's Hosp of Boston
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Springfield, Massachusetts, Spojené státy, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Spojené státy, 016550001
- Univ of Massachusetts Med School
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New Jersey
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Newark, New Jersey, Spojené státy, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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New York
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New Hyde Park, New York, Spojené státy, 11040
- Schneider Children's Hosp
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New York, New York, Spojené státy, 10037
- Harlem Hosp Ctr
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Syracuse, New York, Spojené státy, 13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
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Texas
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Houston, Texas, Spojené státy, 77030
- Texas Children's Hosp / Baylor Univ
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Andrea Kovacs
- Studijní židle: Katherine Luzuriaga
Termíny studijních záznamů
Hlavní termíny studia
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- RNA virové infekce
- Virová onemocnění
- Infekce
- Infekce přenášené krví
- Přenosné nemoci
- Pohlavně přenosné choroby, virové
- Pohlavně přenosné nemoci
- Lentivirové infekce
- Retroviridae infekce
- Syndromy imunologické nedostatečnosti
- Onemocnění imunitního systému
- HIV infekce
- Antiinfekční látky
- Antivirová činidla
- Peginterferon alfa-2b
Další identifikační čísla studie
- P1017
- 11652 (Identifikátor registru: DAIDS ES Registry Number)
- PACTG P1017
- ACTG P1017
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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