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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01328158
First received: April 1, 2011
Last updated: December 12, 2014
Last verified: December 2014
  Purpose

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)

Condition
Human Immunodeficiency Virus Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Drug Reactions [ Time Frame: Up to 60 Months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 236
Study Start Date: June 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lopinavir/Ritonavir
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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# 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# 57650
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# 57644
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.
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01328158     History of Changes
Other Study ID Numbers: P12-760
Study First Received: April 1, 2011
Results First Received: December 12, 2014
Last Updated: December 12, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Infection
Virus Diseases
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Lopinavir
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015