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- Klinische proef 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.)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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California
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Long Beach, California, Verenigde Staten, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, Verenigde Staten, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
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Los Angeles, California, Verenigde Staten, 90033
- Los Angeles County - USC Med Ctr
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San Francisco, California, Verenigde Staten, 941430105
- UCSF / Moffitt Hosp - Pediatric
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Connecticut
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Farmington, Connecticut, Verenigde Staten, 060303805
- Connecticut Children's Med Ctr
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Florida
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Jacksonville, Florida, Verenigde Staten, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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Miami, Florida, Verenigde Staten, 33161
- Univ of Miami (Pediatric)
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 021155724
- Children's Hosp of Boston
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Springfield, Massachusetts, Verenigde Staten, 01199
- Baystate Med Ctr of Springfield
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Worcester, Massachusetts, Verenigde Staten, 016550001
- Univ of Massachusetts Med School
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New Jersey
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Newark, New Jersey, Verenigde Staten, 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, Verenigde Staten, 11040
- Schneider Children's Hosp
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New York, New York, Verenigde Staten, 10037
- Harlem Hosp Ctr
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Syracuse, New York, Verenigde Staten, 13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
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Texas
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Houston, Texas, Verenigde Staten, 77030
- Texas Children's Hosp / Baylor Univ
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Andrea Kovacs
- Studie stoel: Katherine Luzuriaga
Studie record data
Bestudeer belangrijke data
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- HIV-infecties
- Anti-infectieuze middelen
- Antivirale middelen
- Peginterferon alfa-2b
Andere studie-ID-nummers
- P1017
- 11652 (Register-ID: DAIDS ES Registry Number)
- PACTG P1017
- ACTG P1017
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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