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

Study Overview
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Brief Summary
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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)

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

Conditions
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Human Immunodeficiency Virus Infection

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lopinavir/Ritonavir<br>Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Drug Reactions | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |  | 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 |  | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection