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
Results First Received: December 12, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Human Immunodeficiency Virus Infection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Survey forms were collected from 236 patients. 16 participants completed treatment with Lopinavir/Ritonavir tablets before the start of enrollment in this study and were excluded from the analysis.

Reporting Groups
  Description
Lopinavir/Ritonavir Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated

Participant Flow:   Overall Study
    Lopinavir/Ritonavir  
STARTED     220  
COMPLETED     220  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.

Reporting Groups
  Description
Lopinavir/Ritonavir Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated

Baseline Measures
    Lopinavir/Ritonavir  
Number of Participants  
[units: participants]
  220  
Age  
[units: years]
Mean ± Standard Deviation
  43.6  ± 10.1  
Gender  
[units: participants]
 
Female     15  
Male     205  
Presence/Absence of Previous Treatment of HIV-Infection  
[units: participants]
 
Absent     10  
Present     210  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Adverse Drug Reactions   [ Time Frame: Up to 60 Months ]

2.  Primary:   Number of Adverse Drug Reactions   [ Time Frame: Up to 60 Months ]

3.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender   [ Time Frame: Up to 60 Months ]

4.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy   [ Time Frame: Up to 60 Months ]

5.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age   [ Time Frame: Up to 60 Months ]

6.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient   [ Time Frame: Up to 60 Months ]

7.  Secondary:   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 ]

8.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races   [ Time Frame: Up to 60 Months ]

9.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection   [ Time Frame: Up to 60 Months ]

10.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration   [ Time Frame: Up to 60 Months ]

11.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History   [ Time Frame: Up to 60 Months ]

12.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy   [ Time Frame: Up to 60 Months ]

13.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases   [ Time Frame: Up to 60 Months ]

14.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder   [ Time Frame: Up to 60 Months ]

15.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder   [ Time Frame: Up to 60 Months ]

16.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia   [ Time Frame: Up to 60 Months ]

17.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C   [ Time Frame: Up to 60 Months ]

18.  Secondary:   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 ]

19.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir   [ Time Frame: Up to 60 Months ]

20.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir   [ Time Frame: Up to 60 Months ]

21.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir   [ Time Frame: Up to 60 Months ]

22.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs   [ Time Frame: Up to 60 Months ]

23.  Secondary:   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 ]

24.  Secondary:   Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs   [ Time Frame: Up to 60 Months ]

25.  Secondary:   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 ]

26.  Secondary:   Number of Participants With Serious Adverse Events   [ Time Frame: Up to 60 Months ]

27.  Secondary:   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 ]

28.  Secondary:   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 ]

29.  Secondary:   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 ]

30.  Secondary:   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 ]

31.  Secondary:   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 ]

32.  Secondary:   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 ]

33.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: AbbVie Japan PMOS Desk
Organization: AbbVie (prior sponsor, Abbott)
phone: +81-3-4577-1125
e-mail: abvj-pmos@abbvie.com


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