- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00982553
The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
A Prospective, Open-label, Three Phase Pharmacokinetic Study, to Assess the Pharmacokinetic Profile and Safety of Raltegravir 400 mg Twice Daily and Ribavirin 800 mg Once Daily, When Dosed Separately and Together in Healthy Volunteers
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Phase I (study day 1 - 14):
- 14 healthy volunteers with a documented negative HIV-1 antibody test during screening procedures will be enrolled.
- On day 1, fasted subjects will be administered ribavirin 800 mg without food (witnessed dosing). This will be followed be a 12 hour detailed pharmacokinetic assessment; blood sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours.
- This will be followed by a wash-out period.
- As steady state pharmacokinetics of ribavirin are not reached for several weeks, single dosing pharmacokinetics will be assessed in this study
Phase II (study days 15 - 19):
- On day 15, subjects will commence raltegravir 400 mg twice daily. Subjects will attend for safety visits and witnessed dosing during this phase.
- Day 19 - after 4 days of dosing when steady state pharmacokinetics has been reached, subjects will attend for a 12 hour detailed pharmacokinetic visit where following witnessed administration of raltegravir 400 mg without food, blood sampling will be drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post dose for the assessment of raltegravir plasma exposure.
Phase III (study day 20):
• Subjects will be administered raltegravir 400 mg and ribavirin 800 mg without food. This will be followed by a 12 hour detailed pharmacokinetic assessment with blood sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
-
London, Royaume-Uni, W2 1NY
- Imperial College Healthcare NHS Trust
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
- Male or non-pregnant, non-lactating female.
- Between 18 to 60 years, inclusive.
- Subjects in good health upon medical history, physical exam, and laboratory testing and body mass index below 32.
Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study including 180 days following last dose of study drug:
- barrier contraceptives (condom, diaphragm with spermicide)
- oral combined contraceptive pill, implant or injectable hormonal contraceptive PLUS a barrier contraceptive
- Intrauterine device (IUD) or intrauterine system (IUS) PLUS a barrier contraceptive (or a partner who has been vasectomized for at least six months).
- Female subjects of childbearing potential must have a negative urine pregnancy test.
- Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study including 180 days following last dose of study drug.
- Have no serologic evidence of HIV infection.
- Have no serologic evidence of active hepatitis B virus infection evidenced by negative hepatitis B surface antigen and no serologic evidence of hepatitis C virus infection through antibody testing.
- Have screening laboratory results (haematology, chemistry) that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance.
Exclusion Criteria:
- Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy.
- Have a body mass index (BMI) greater than 32
- Previous participation in an investigational trial involving administration of any investigational compound within 1 month prior to the study screening.
- Clinically relevant alcohol or drug use (positive screening drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
- Any medication taken listed in Prior and Concomitant Medication section including over-the-counter medications and herbal products within 21 days of commencing study drug dosing with the exception of vitamins and/or paracetamol and/or hormonal contraceptives including the combined oral contraceptive pill, Depo-Provera and the Mirena intrauterine system. When a concomitant medication is necessary, this will be reviewed by the Investigator and if not contraindicated, may be continued at the same dose and frequency during the study period.
- History of drug sensitivity or drug allergy.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Phase 1_ribavirin
Treatment with Single dose ribavirin (800 mg) administered on day 1
|
800mg once daily
Autres noms:
|
Expérimental: Phase2_raltegravir
Treatment with Raltegravir (400 mg twice daily) administered from days 15-19
|
400 mg deux fois par jour
|
Expérimental: Phase3_ribavirin+raltegravir
Treatment with Ribavirin (800 mg) and Raltegravir (400 mg) administered day 20
|
400 mg deux fois par jour
800mg once daily
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Ribavirin Maximum Plasma Concentration
Délai: Day 20
|
Pharmacokinetic analyses of blood samples
|
Day 20
|
Raltegravir Maximum Plasma Concentration
Délai: Day 20
|
Day 20
|
|
Ribavirin Minimum Plasma Concentration
Délai: Day 20
|
Ribavirin minimum plasma concentration by pharmacokinetic analyses
|
Day 20
|
Raltegravir Minimum Plasma Concentrations
Délai: Day 20
|
Raltegravir minimum plasma concentrations by pharmacokinetic analyses
|
Day 20
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Alan Winston, MB BH, Imperial College London
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
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
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Inhibiteurs d'enzymes
- Agents anti-VIH
- Agents antirétroviraux
- Antimétabolites
- Inhibiteurs de l'intégrase du VIH
- Inhibiteurs de l'intégrase
- Ribavirine
- Raltégravir potassique
Autres numéros d'identification d'étude
- 2009-010005-36 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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
-
Radboud University Medical CenterSint MaartenskliniekActif, ne recrute pasInfection du site opératoire | Infection articulaire | Infection, site chirurgical | Prothèse Infection Hanche et Genou | Infection liée aux prothèses | InfectionProPays-Bas
-
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
-
Taipei Medical University WanFang HospitalInconnue
-
Ondine Biomedical Inc.ComplétéInfection du site opératoire | Infection nosocomiale | Infection associée aux soins de santéÉtats-Unis
-
Croydon Health Services NHS TrustComplétéInfection du site opératoire | Infection de la plaie | Césarienne; Infection | Infection périnéaleRoyaume-Uni
-
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