Clinical trial NCT01328158: Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
Official title: Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus Infection
Keywords: Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-04-04
Enrollment: 236
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who receive Kaletra for the treatment of Human Immunodeficiency Virus infection per approved label

Brief 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)


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Adverse Drug Reactions
timeFrame: Up to 60 Months
measure: Number of Adverse Drug Reactions
timeFrame: Up to 60 Months
Secondary outcomes:
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs
timeFrame: Up to 60 Months
measure: Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs
timeFrame: Up to 60 Months
measure: Number of Participants With Serious Adverse Events
timeFrame: Up to 60 Months
measure: Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation
timeFrame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
measure: Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation
timeFrame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
measure: Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation
timeFrame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
measure: Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation
timeFrame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
measure: Number of Participants in Each CDC Classification Category of HIV-infection Over Time
timeFrame: Up to Month 60 after first dose of Lopinavir/Ritonavir
measure: Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants
timeFrame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
measure: Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants
timeFrame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Site Reference ID/Investigator# 57629
city: Hiroshima-shi
country: Japan
facility: Site Reference ID/Investigator# 57630
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 57631
city: Kitakyushu-shi
country: Japan
facility: Site Reference ID/Investigator# 57628
city: Kurashiki-shi
country: Japan
facility: Site Reference ID/Investigator# 57638
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 57634
city: Nagoya-shi
country: Japan
facility: Site Reference ID/Investigator# 57625
city: Nagoya-shi
country: Japan
facility: Site Reference ID/Investigator# 57626
city: Niigata
country: Japan
facility: Site Reference ID/Investigator# 57637
city: Nishinomiya-shi
country: Japan
facility: Site Reference ID/Investigator# 57632
city: Osaka-shi
country: Japan
facility: Site Reference ID/Investigator# 57639
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 57640
city: Sendai-shi
country: Japan
facility: Site Reference ID/Investigator# 57636
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 48722
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 57641
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 57643
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 57644
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 57645
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 57646
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 57647
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 57648
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 57650
city: Yokohama-shi
country: Japan
facility: Site Reference ID/Investigator# 57633
Study officials:
affiliation: AbbVie G.K.
name: Susumu Adachi, MD
role: STUDY_DIRECTOR
References: