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Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection

12 décembre 2014 mis à jour par: AbbVie (prior sponsor, Abbott)

Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection

This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug:

Incidence and conditions of occurrence of adverse reactions in the clinical setting
Factors that may affect the safety and effectiveness of Kaletra (QD)

Aperçu de l'étude

Statut

Complété

Les conditions

Infection par le virus de l'immunodéficience humaine

Type d'étude

Observationnel

Inscription (Réel)

236

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Japon
- - Fukuoka-shi, Japon
    - Site Reference ID/Investigator# 57629
  - Hiroshima-shi, Japon
    - Site Reference ID/Investigator# 57630
  - Hokkaido, Japon
    - Site Reference ID/Investigator# 57631
  - Kitakyushu-shi, Japon
    - Site Reference ID/Investigator# 57628
  - Kurashiki-shi, Japon
    - Site Reference ID/Investigator# 57638
  - Kyoto, Japon
    - Site Reference ID/Investigator# 57634
  - Nagoya-shi, Japon
    - Site Reference ID/Investigator# 57625
  - Nagoya-shi, Japon
    - Site Reference ID/Investigator# 57626
  - Niigata, Japon
    - Site Reference ID/Investigator# 57637
  - Nishinomiya-shi, Japon
    - Site Reference ID/Investigator# 57632
  - Osaka, Japon
    - Site Reference ID/Investigator# 57640
  - Osaka-shi, Japon
    - Site Reference ID/Investigator# 57639
  - Sendai-shi, Japon
    - Site Reference ID/Investigator# 57636
  - Tokyo, Japon
    - Site Reference ID/Investigator# 48722
  - Tokyo, Japon
    - Site Reference ID/Investigator# 57641
  - Tokyo, Japon
    - Site Reference ID/Investigator# 57643
  - Tokyo, Japon
    - Site Reference ID/Investigator# 57644
  - Tokyo, Japon
    - Site Reference ID/Investigator# 57645
  - Tokyo, Japon
    - Site Reference ID/Investigator# 57646
  - Tokyo, Japon
    - Site Reference ID/Investigator# 57647
  - Tokyo, Japon
    - Site Reference ID/Investigator# 57648
  - Tokyo, Japon
    - Site Reference ID/Investigator# 57650
  - Yokohama-shi, Japon
    - Site Reference ID/Investigator# 57633

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

All participants who receive Kaletra for the treatment of Human Immunodeficiency Virus infection per approved label

La description

Inclusion Criteria:

- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.

Exclusion Criteria:

Participants with a history of hypersensitivity to any ingredient of this drug.
Participants who are undergoing treatment with any of the following drugs: pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, sildenafil citrate (Revatio), tadalafil (Adcirca), blonanserin, azelnidipine, rivaroxaban, voriconazole.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Lopinavir/Ritonavir Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Percentage of Participants With Adverse Drug Reactions Délai: Up to 60 Months	Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Adverse Drug Reactions Délai: Up to 60 Months	Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown". Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors.	Up to 60 Months
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs Délai: Up to 60 Months	Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".	Up to 60 Months
Number of Participants With Serious Adverse Events Délai: Up to 60 Months	A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above.	Up to 60 Months
Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation Délai: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir		Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation Délai: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir		Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation Délai: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir	For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.	Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation Délai: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir	For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.	Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Number of Participants in Each CDC Classification Category of HIV-infection Over Time Délai: Up to Month 60 after first dose of Lopinavir/Ritonavir	CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.	Up to Month 60 after first dose of Lopinavir/Ritonavir
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants Délai: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir	Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.	Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants Délai: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir	Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.	Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

AbbVie (prior sponsor, Abbott)

Les enquêteurs

Directeur d'études: Susumu Adachi, MD, AbbVie G.K.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Related Info

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2011

Achèvement primaire (Réel)

1 décembre 2013

Achèvement de l'étude (Réel)

1 décembre 2013

Dates d'inscription aux études

Première soumission

1 avril 2011

Première soumission répondant aux critères de contrôle qualité

1 avril 2011

Première publication (Estimation)

4 avril 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

22 décembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 décembre 2014

Dernière vérification

1 décembre 2014

Plus d'information

Termes liés à cette étude

Mots clés

Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

P12-760

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 .