Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Immunodeficiency Virus Infection
Phase: N/A
Status: Completed
Sponsored by: AbbVie (prior sponsor, Abbott) Official(s) and/or principal investigator(s): Susumu Adachi, MD, Study Director, Affiliation: AbbVie G.K.
Summary
This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify
the following with regard to treatment with this drug:
1. Incidence and conditions of occurrence of adverse reactions in the clinical setting
2. Factors that may affect the safety and effectiveness of Kaletra (QD)
Clinical Details
Official title: Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Percentage of Participants With Adverse Drug ReactionsNumber of Adverse Drug Reactions
Secondary outcome: Number of Participants With Adverse Drug Reaction by Patient Characteristic: GenderNumber of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs Number of Participants With Serious Adverse Events Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation Number of Participants in Each CDC Classification Category of HIV-infection Over Time Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Site Reference ID/Investigator# 57629, Fukuoka-shi, Japan
Site Reference ID/Investigator# 57630, Hiroshima-shi, Japan
Site Reference ID/Investigator# 57631, Hokkaido, Japan
Site Reference ID/Investigator# 57628, Kitakyushu-shi, Japan
Site Reference ID/Investigator# 57638, Kurashiki-shi, Japan
Site Reference ID/Investigator# 57634, Kyoto, Japan
Site Reference ID/Investigator# 57625, Nagoya-shi, Japan
Site Reference ID/Investigator# 57626, Nagoya-shi, Japan
Site Reference ID/Investigator# 57637, Niigata, Japan
Site Reference ID/Investigator# 57632, Nishinomiya-shi, Japan
Site Reference ID/Investigator# 57639, Osaka-shi, Japan
Site Reference ID/Investigator# 57640, Osaka, Japan
Site Reference ID/Investigator# 57636, Sendai-shi, Japan
Site Reference ID/Investigator# 48722, Tokyo, Japan
Site Reference ID/Investigator# 57641, Tokyo, Japan
Site Reference ID/Investigator# 57643, Tokyo, Japan
Site Reference ID/Investigator# 57644, Tokyo, Japan
Site Reference ID/Investigator# 57645, Tokyo, Japan
Site Reference ID/Investigator# 57646, Tokyo, Japan
Site Reference ID/Investigator# 57647, Tokyo, Japan
Site Reference ID/Investigator# 57648, Tokyo, Japan
Site Reference ID/Investigator# 57650, Tokyo, Japan
Site Reference ID/Investigator# 57633, Yokohama-shi, Japan
Additional Information
Starting date: June 2011
Last updated: December 12, 2014
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