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Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (KaleEAST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01379703
First received: June 22, 2011
Last updated: October 10, 2011
Last verified: October 2011
Results First Received: August 9, 2011  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: HIV-1 Patients

  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
The study was carried out in two parts. The first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation (Part I) and the second part (Part II) started in 2006 after the tablet formulation became available in participating countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tablets and Capsules or Oral Solution HIV-1 infected participants who received both tablet and capsule formulations or oral solution.
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Participant Flow for 2 periods

Period 1:   Study Start Through 9 Months
    Tablets and Capsules or Oral Solution   Capsule Formulation   Tablet Formulation
STARTED   66 [1]   1206 [2]   1016 [3] 
COMPLETED   62   1084 [4]   873 
NOT COMPLETED   4   122   143 
Lost to Follow-up                2                61                104 
Adverse Event                0                14                10 
Withdrawal by Subject                0                6                1 
Treatment Failure                0                2                2 
Patient Noncompliance                0                0                1 
Tuberculosis/TB treatment                0                4                0 
Medication not available                0                2                1 
Poor general condition                0                1                0 
Increased triglycerides                0                1                0 
Reason unknown                2                31                24 
[1] Participants taking lopinavir/ritonavir tablets/capsules or oral solution during the study (66/2288)
[2] Participants taking the lopinavir/ritonavir capsule formulation (only) during study (1206/2288)
[3] Participants taking the lopinavir/ritonavir tablet formulation (only) during study (1016/2288)
[4] Participants taking the capsule formulation were followed for an additional 9 months (up to 18 mos).

Period 2:   9 Months Through 18 Months
    Tablets and Capsules or Oral Solution   Capsule Formulation   Tablet Formulation
STARTED   0 [1]   1084 [2]   0 [1] 
COMPLETED   0   854   0 
NOT COMPLETED   0   230   0 
Lost to Follow-up                0                178                0 
Withdrawal by Subject                0                11                0 
Adverse Event                0                6                0 
Treatment failure                0                5                0 
Patient Noncompliance                0                4                0 
Tuberculosis/TB treatment                0                2                0 
Fatigue                0                1                0 
Reason Unknown                0                23                0 
[1] Participants in this subgroup were followed for 9 months.
[2] Participants taking the capsule formulation were followed for an additional 9 months (up to 18 mos).



  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.
No text entered.

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.

Baseline Measures
   Total Study Population 
Overall Participants Analyzed 
[Units: Participants]
 2288 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.6  (11.0) 
Gender, Customized 
[Units: Participants]
 
Female   867 
Male   1419 
Data not reported   2 
Region of Enrollment 
[Units: Participants]
 
Serbia   149 
Czech Republic   107 
Slovenia   123 
Slovakia   26 
Poland   381 
Ukraine   266 
Romania   422 
Lithuania   3 
Russian Federation   644 
Israel   139 
Georgia   10 
Latvia   18 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   CD4 Count   [ Time Frame: Baseline ]

2.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 1 month ]

3.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 3 months ]

4.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 6 months ]

5.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 9 months ]

6.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 12 months ]

7.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 15 months ]

8.  Primary:   Changes in CD4 Count   [ Time Frame: Baseline to 18 months ]

9.  Primary:   Viral Load   [ Time Frame: Baseline ]

10.  Primary:   Viral Load   [ Time Frame: 1 month ]

11.  Primary:   Viral Load   [ Time Frame: 3 months ]

12.  Primary:   Viral Load   [ Time Frame: 6 months ]

13.  Primary:   Viral Load   [ Time Frame: 9 months ]

14.  Primary:   Viral Load   [ Time Frame: 12 months ]

15.  Primary:   Viral Load   [ Time Frame: 15 months ]

16.  Primary:   Viral Load   [ Time Frame: 18 months ]

17.  Primary:   Laboratory Parameter Blood Glucose   [ Time Frame: Baseline, 9 months, 18 months ]

18.  Primary:   Laboratory Parameter Transaminases   [ Time Frame: Baseline, 9 months, 18 months ]

19.  Primary:   Laboratory Parameter Lipids   [ Time Frame: Baseline, 9 months, 18 months ]

20.  Secondary:   Reasons for Discontinuation of Lopinavir/Ritonavir   [ Time Frame: 9 months ]

21.  Secondary:   Reasons for Discontinuation of Lopinavir/Ritonavir   [ Time Frame: 18 months ]

22.  Secondary:   Compliance With Lopinavir/Ritonavir   [ Time Frame: 9 months ]

23.  Secondary:   Compliance With Lopinavir/Ritonavir   [ Time Frame: 18 months ]

24.  Secondary:   Adverse Events Observed on Treatment With Lopinavir/Ritonavir.   [ Time Frame: 18 months ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Study start through 9 months for all participants, and study start through 18 months for participants receiving lopinavir/ritonavir capsules.
Additional Description Adverse events (AEs) and Serious AEs occurring during the study were recorded. Serious AEs were reported from the time the physician obtained the patient's authorization to use and disclose information (or the patient's informed consent) until 30 days following intake of the last dose of the physician-prescribed lopinavir/ritonavir treatment.

Frequency Threshold
Threshold above which other adverse events are reported   0.2  

Reporting Groups
  Description
Total Study Population HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
Capsule Formulation Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
Tablet Formulation Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.

Other Adverse Events
    Total Study Population   Capsule Formulation   Tablet Formulation
Total, other (not including serious) adverse events       
# participants affected / at risk   109/2288 (4.76%)   77/1206 (6.38%)   34/1016 (3.35%) 
Blood and lymphatic system disorders       
Anaemia † 1       
# participants affected / at risk   4/2288 (0.17%)   3/1206 (0.25%)   1/1016 (0.10%) 
Gastrointestinal disorders       
Abdominal pain † 1       
# participants affected / at risk   5/2288 (0.22%)   2/1206 (0.17%)   3/1016 (0.30%) 
Abdominal pain upper † 1       
# participants affected / at risk   8/2288 (0.35%)   6/1206 (0.50%)   2/1016 (0.20%) 
Diarrhoea † 1 [3]       
# participants affected / at risk   67/2288 (2.93%)   43/1206 (3.57%)   21/1016 (2.07%) 
Flatulence † 1       
# participants affected / at risk   3/2288 (0.13%)   3/1206 (0.25%)   0/1016 (0.00%) 
Gastrointestinal disorder † 1       
# participants affected / at risk   4/2288 (0.17%)   1/1206 (0.08%)   3/1016 (0.30%) 
Nausea † 1 [3]       
# participants affected / at risk   38/2288 (1.66%)   30/1206 (2.49%)   7/1016 (0.69%) 
Vomiting † 1 [3]       
# participants affected / at risk   24/2288 (1.05%)   17/1206 (1.41%)   6/1016 (0.59%) 
General disorders       
Asthenia † 1       
# participants affected / at risk   10/2288 (0.44%)   6/1206 (0.50%)   4/1016 (0.39%) 
Fatigue † 1 [3]       
# participants affected / at risk   6/2288 (0.26%)   4/1206 (0.33%)   1/1016 (0.10%) 
Immune system disorders       
Drug hypersensitivity † 1       
# participants affected / at risk   3/2288 (0.13%)   3/1206 (0.25%)   0/1016 (0.00%) 
Investigations       
Weight decreased † 1       
# participants affected / at risk   3/2288 (0.13%)   3/1206 (0.25%)   0/1016 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite † 1       
# participants affected / at risk   4/2288 (0.17%)   3/1206 (0.25%)   1/1016 (0.10%) 
Hypertriglyceridaemia † 1       
# participants affected / at risk   6/2288 (0.26%)   5/1206 (0.41%)   1/1016 (0.10%) 
Nervous system disorders       
Headache † 1       
# participants affected / at risk   6/2288 (0.26%)   5/1206 (0.41%)   1/1016 (0.10%) 
Psychiatric disorders       
Depression † 1       
# participants affected / at risk   3/2288 (0.13%)   3/1206 (0.25%)   0/1016 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus † 1       
# participants affected / at risk   5/2288 (0.22%)   4/1206 (0.33%)   1/1016 (0.10%) 
Rash † 1       
# participants affected / at risk   3/2288 (0.13%)   3/1206 (0.25%)   0/1016 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.1
[3] One or more adverse events occurred in the 66 participants receiving both capsules and tablets, or oral solution.



  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: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110



Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01379703     History of Changes
Other Study ID Numbers: PMOS-EAST-04-1
Study First Received: June 22, 2011
Results First Received: August 9, 2011
Last Updated: October 10, 2011
Health Authority: Romania: Ethics Committee
Romania: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Serbia: Ethics Committee
Israel: Ethics Commission
Israel: Ministry of Health
Slovenia: Ethics Committee
Slovak Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Latvia: Institutional Review Board
Latvia: State Agency of Medicines
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health