Human Immunodeficiency Virus Infection Clinical Trial
Official title:
Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection
Verified date | December 2014 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Observational |
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)
Status | Completed |
Enrollment | 236 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Japan | 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# 57640 | Osaka | |
Japan | Site Reference ID/Investigator# 57639 | Osaka-shi | |
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 |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Primary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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