Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
- Conditions
- Human Immunodeficiency Virus Infection
- Registration Number
- NCT01328158
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Drug Reactions 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".
Number of Adverse Drug Reactions 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".
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia 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".
Number of Participants With Serious Adverse Events 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.
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs 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".
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 HIV RNA Amount 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 For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL.
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir 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".
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 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.
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants 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.
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants 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.
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs 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".
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs 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.
Number of Participants in Each CDC Classification Category of HIV-infection Over Time 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.
Trial Locations
- Locations (23)
Site Reference ID/Investigator# 57631
🇯🇵Hokkaido, Japan
Site Reference ID/Investigator# 57628
🇯🇵Kitakyushu-shi, Japan
Site Reference ID/Investigator# 57634
🇯🇵Kyoto, Japan
Site Reference ID/Investigator# 57626
🇯🇵Nagoya-shi, Japan
Site Reference ID/Investigator# 57639
🇯🇵Osaka-shi, Japan
Site Reference ID/Investigator# 57641
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 57644
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 57640
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 57645
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 57638
🇯🇵Kurashiki-shi, Japan
Site Reference ID/Investigator# 57636
🇯🇵Sendai-shi, Japan
Site Reference ID/Investigator# 57646
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 57647
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 57630
🇯🇵Hiroshima-shi, Japan
Site Reference ID/Investigator# 57643
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 57632
🇯🇵Nishinomiya-shi, Japan
Site Reference ID/Investigator# 48722
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 57637
🇯🇵Niigata, Japan
Site Reference ID/Investigator# 57629
🇯🇵Fukuoka-shi, Japan
Site Reference ID/Investigator# 57625
🇯🇵Nagoya-shi, Japan
Site Reference ID/Investigator# 57648
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 57650
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 57633
🇯🇵Yokohama-shi, Japan