Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
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| ClinicalTrials.gov Identifier: NCT01328158 |
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Recruitment Status
:
Completed
First Posted
: April 4, 2011
Results First Posted
: December 22, 2014
Last Update Posted
: December 22, 2014
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Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
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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:
- Incidence and conditions of occurrence of adverse reactions in the clinical setting
- Factors that may affect the safety and effectiveness of Kaletra (QD)
| Condition or disease |
|---|
| Human Immunodeficiency Virus Infection |
| Study Type : | Observational |
| Actual Enrollment : | 236 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection |
| Study Start Date : | June 2011 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | December 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Group/Cohort |
|---|
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Lopinavir/Ritonavir
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
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Primary Outcome Measures
:
- Percentage of Participants With Adverse Drug Reactions [ Time Frame: 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 [ Time Frame: 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
:
- Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender [ Time Frame: 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 Pregnancy [ Time Frame: 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: Age [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Diseases [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 With/Without Hepatitis C [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs [ Time Frame: 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 [ Time Frame: 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.
- Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation [ Time Frame: 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 in Each CDC Classification Category of HIV-infection Over Time [ Time Frame: 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.
- Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All participants who receive Kaletra for the treatment of Human Immunodeficiency Virus infection per approved label
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328158
Locations
| 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# 57639 | |
| Osaka-shi, Japan | |
| Site Reference ID/Investigator# 57640 | |
| Osaka, 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, Japan | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Susumu Adachi, MD | AbbVie G.K. |
Additional Information:
| Responsible Party: | AbbVie (prior sponsor, Abbott) |
| ClinicalTrials.gov Identifier: | NCT01328158 History of Changes |
| Other Study ID Numbers: |
P12-760 |
| First Posted: | April 4, 2011 Key Record Dates |
| Results First Posted: | December 22, 2014 |
| Last Update Posted: | December 22, 2014 |
| Last Verified: | December 2014 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
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Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection |
Additional relevant MeSH terms:
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Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases |
Ritonavir Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |