Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets) (QD-Kapital)

This study has been completed.
Sponsor:
Collaborator:
Triaca Magna, SA
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01383005
First received: May 31, 2011
Last updated: April 30, 2013
Last verified: April 2013
Results First Received: December 28, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Human Immunodeficiency Virus Infection

  Participant Flow
  Hide Participant Flow

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
97 participants were enrolled; 3 participants who did not meet the inclusion criteria for treatment duration were excluded.

Reporting Groups
  Description
Kaletra (LPV/r) QD as First Kaletra Treatment HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Kaletra (LPV/r) QD From Kaletra BID HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.

Participant Flow:   Overall Study
    Kaletra (LPV/r) QD as First Kaletra Treatment     Kaletra (LPV/r) QD From Kaletra BID  
STARTED     34     60  
COMPLETED     34     60  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Kaletra (LPV/r) QD as First Kaletra Treatment HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
Kaletra (LPV/r) QD From Kaletra BID HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
Total Total of all reporting groups

Baseline Measures
    Kaletra (LPV/r) QD as First Kaletra Treatment     Kaletra (LPV/r) QD From Kaletra BID     Total  
Number of Participants  
[units: participants]
  34     60     94  
Age  
[units: years]
Mean ± Standard Deviation
  36.2  ± 9.4     39.9  ± 8.8     38.6  ± 9.2  
Gender  
[units: participants]
     
Female     9     21     30  
Male     25     39     64  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

2.  Primary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

3.  Secondary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

4.  Secondary:   Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

5.  Secondary:   Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

6.  Secondary:   Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

7.  Secondary:   Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

8.  Secondary:   Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

9.  Secondary:   Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

10.  Secondary:   Mean Number of Days on LPV/r QD   [ Time Frame: At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD ]

11.  Secondary:   Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies   [ Time Frame: at the single study visit, performed after at least 12 weeks of treatment with Kaletra ]

12.  Secondary:   Percentage of Participants With Missing Doses During “the Past 4 Days” and “the Last Weekend” in KAPITAL-2 and QD-KAPITAL Studies   [ Time Frame: at the single study visit, performed after at least 12 weeks of treatment with Kaletra ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Collected at the single study visit, performed after at least 12 weeks of treatment with Kaletra QD
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Overall Study Population

HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.

Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.


Other Adverse Events
    Overall Study Population  
Total, other (not including serious) adverse events    
# participants affected / at risk     13/94  
Gastrointestinal disorders    
Diarrhea † 1  
# participants affected / at risk     10/94 (10.64%)  
Nausea † 1  
# participants affected / at risk     2/94 (2.13%)  
Dyspepsia † 1  
# participants affected / at risk     1/94 (1.06%)  
General disorders    
Burning Sensation † 1  
# participants affected / at risk     2/94 (2.13%)  
Musculoskeletal and connective tissue disorders    
Musculoskeletal pain † 1  
# participants affected / at risk     2/94 (2.13%)  
Reproductive system and breast disorders    
Sexual Disorder NOS † 1  
# participants affected / at risk     1/94 (1.06%)  
Skin and subcutaneous tissue disorders    
Skin Disorders NOS † 1  
# participants affected / at risk     1/94 (1.06%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 15.1



  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01383005     History of Changes
Other Study ID Numbers: P12-752
Study First Received: May 31, 2011
Results First Received: December 28, 2012
Last Updated: April 30, 2013
Health Authority: Spain: Spanish Agency of Medicines