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

Human Immunodeficiency Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328158
• Other study ID #: P12-760
• Status: Completed
• Phase: N/A
• First received: April 1, 2011
• Last updated: December 12, 2014
• Start date: June 2011
• Est. completion date: December 2013

Study information

• 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

Clinical Trial 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)

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Human Immunodeficiency Virus Infection
• Immunologic Deficiency Syndromes
• Infection
• Virus Diseases

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Japan, 

Outcome

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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