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

April 1, 2011
December 12, 2014
June 2011
December 2013   (final data collection date for primary outcome measure)
  • 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".
  • Number of patients with adverse events [ Time Frame: at week 52 ] [ Designated as safety issue: Yes ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Kaletra
  • Cluster of differentiation 4 lymphocyte count, number of Human Immunodeficiency Virus-ribo nucleic acid copies, Centers for Disease Control and Prevention classification [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01328158 on ClinicalTrials.gov Archive Site
  • 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.
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Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection

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)
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

All participants who receive Kaletra for the treatment of Human Immunodeficiency Virus infection per approved label

Human Immunodeficiency Virus Infection
Not Provided
Lopinavir/Ritonavir
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
236
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01328158
P12-760
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Susumu Adachi, MD AbbVie G.K.
AbbVie
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP