- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
California
-
Long Beach, California, États-Unis, 90801
- Long Beach Memorial (Pediatric)
-
Los Angeles, California, États-Unis, 900276016
- Children's Hosp of Los Angeles/UCLA Med Ctr
-
Los Angeles, California, États-Unis, 90033
- Los Angeles County - USC Med Ctr
-
San Francisco, California, États-Unis, 941430105
- UCSF / Moffitt Hosp - Pediatric
-
-
Connecticut
-
Farmington, Connecticut, États-Unis, 060303805
- Connecticut Children's Med Ctr
-
-
Florida
-
Jacksonville, Florida, États-Unis, 32209
- Univ of Florida Health Science Ctr / Pediatrics
-
Miami, Florida, États-Unis, 33161
- Univ of Miami (Pediatric)
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 021155724
- Children's Hosp of Boston
-
Springfield, Massachusetts, États-Unis, 01199
- Baystate Med Ctr of Springfield
-
Worcester, Massachusetts, États-Unis, 016550001
- Univ of Massachusetts Med School
-
-
New Jersey
-
Newark, New Jersey, États-Unis, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
-
-
New York
-
New Hyde Park, New York, États-Unis, 11040
- Schneider Children's Hosp
-
New York, New York, États-Unis, 10037
- Harlem Hosp Ctr
-
Syracuse, New York, États-Unis, 13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
-
-
Texas
-
Houston, Texas, États-Unis, 77030
- Texas Children's Hosp / Baylor Univ
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: Andrea Kovacs
- Chaise d'étude: Katherine Luzuriaga
Dates d'enregistrement des études
Dates principales de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Maladies du système immunitaire
- Infections à VIH
- Agents anti-infectieux
- Agents antiviraux
- Peginterféron alfa-2b
Autres numéros d'identification d'étude
- P1017
- 11652 (Identificateur de registre: DAIDS ES Registry Number)
- PACTG P1017
- ACTG P1017
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Infections à VIH
-
Icahn School of Medicine at Mount SinaiIRRASRecrutementHémorragie intraventriculaire (HIV)États-Unis
-
Yale UniversityComplétéPrématurité | Nourrissons de très faible poids à la naissance | Hémorragie intraventriculaire (HIV) | Saignement dans le cerveauÉtats-Unis
-
West Virginia UniversityInscription sur invitationInfection de la peau et des tissus mous | Infection gastro-intestinale | Infection pulmonaire | Infection des os et des articulations | Infection endovasculaire | Infection génito-urinaireÉtats-Unis
-
Croydon Health Services NHS TrustComplétéInfection du site opératoire | Infection de la plaie | Césarienne; Infection | Infection périnéaleRoyaume-Uni
-
Taipei Medical University WanFang HospitalInconnue
-
Ondine Biomedical Inc.ComplétéInfection du site opératoire | Infection nosocomiale | Infection associée aux soins de santéÉtats-Unis
-
Angela BiancoStryker NordicRésiliéCésarienne | Infection du site opératoire | Infection nosocomialeÉtats-Unis
-
Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... et autres collaborateursRecrutementInfection prothétique-articulaire | Infection de la hanche | Infection; Genou, ArticulationPays-Bas
-
Cairo UniversityRecrutementInfection postopératoire | Complications de la césarienne | Infection vaginaleEgypte
-
Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemComplétéInfection du site opératoire | Infection superficielle du site opératoire | Infection profonde du site chirurgical | Infection du site chirurgical d'un organe/de l'espaceÉtats-Unis
Essais cliniques sur Peginterféron alfa-2b
-
PharmaEssentiaRecrutementPolyglobulie VeraÉtats-Unis, Canada
-
The University of Hong KongRecrutementMyélofibrose | Myélofibrose primaire, stade préfibrotiqueHong Kong
-
BiocadComplétéHépatite | Hépatite C | Coinfection hépatite C/virus de l'immunodéficience humaineFédération Russe
-
PharmaEssentia Japan K.K.PharmaEssentiaComplété
-
PharmaEssentiaPas encore de recrutementPolyglobulie Vera | Tumeur myéloproliférative
-
Foundation for Liver ResearchComplété
-
Merck Sharp & Dohme LLCRésilié
-
Xiamen Amoytop Biotech Co., Ltd.Peking University People's HospitalComplétéHépatite C chroniqueChine
-
Third Affiliated Hospital, Sun Yat-Sen UniversityPeking University; Huazhong University of Science and Technology; First People... et autres collaborateursInconnue
-
Third Affiliated Hospital, Sun Yat-Sen UniversityPeking University; Huazhong University of Science and Technology; First People... et autres collaborateursInconnue