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

Baseline Measures
    Total Study Population  
Number of Participants  
[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
  Hide Serious Adverse Events

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.

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.

Serious Adverse Events
    Total Study Population     Capsule Formulation     Tablet Formulation  
Total, serious adverse events        
# participants affected / at risk     46/2288 (2.01%)     22/1206 (1.82%)     22/1016 (2.17%)  
Blood and lymphatic system disorders        
Anaemia † 1      
# participants affected / at risk     3/2288 (0.13%)     2/1206 (0.17%)     1/1016 (0.10%)  
Haemolytic anaemia † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Lymphadenopathy † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Thrombocytopenia † 1      
# participants affected / at risk     2/2288 (0.09%)     1/1206 (0.08%)     1/1016 (0.10%)  
Eye disorders        
Exophthalmos † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Iridocyclitis † 1      
# participants affected / at risk     2/2288 (0.09%)     0/1206 (0.00%)     2/1016 (0.20%)  
Mydriasis † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Gastrointestinal disorders        
Abdominal pain † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Diarrhoea † 1      
# participants affected / at risk     4/2288 (0.17%)     1/1206 (0.08%)     3/1016 (0.30%)  
Vomiting † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
General disorders        
Asthenia † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Chest pain † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Death † 1      
# participants affected / at risk     7/2288 (0.31%)     2/1206 (0.17%)     5/1016 (0.49%)  
Fatigue † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Pyrexia † 1      
# participants affected / at risk     3/2288 (0.13%)     3/1206 (0.25%)     0/1016 (0.00%)  
Infections and infestations        
Acquired immunodeficiency syndrome † 1      
# participants affected / at risk     2/2288 (0.09%)     2/1206 (0.17%)     0/1016 (0.00%)  
Acute sinusitis † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Bronchitis † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Cellulitis † 1      
# participants affected / at risk     2/2288 (0.09%)     1/1206 (0.08%)     1/1016 (0.10%)  
Cerebral toxoplasmosis † 1      
# participants affected / at risk     2/2288 (0.09%)     0/1206 (0.00%)     2/1016 (0.20%)  
Encephalitis cytomegalovirus † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Hepatitis C † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Meningitis cryptococcal † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Mycobacterium avium complex infection † 1      
# participants affected / at risk     2/2288 (0.09%)     0/1206 (0.00%)     2/1016 (0.20%)  
Pharyngitis † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Pneumocystis jiroveci pneumonia † 1      
# participants affected / at risk     2/2288 (0.09%)     2/1206 (0.17%)     0/1016 (0.00%)  
Pneumonia † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Septic shock † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Tuberculosis † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Investigations        
Mycobacteria test † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Metabolism and nutrition disorders        
Cachexiae † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Diabetes mellitus † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Musculoskeletal and connective tissue disorders        
Musculoskeletal stiffness † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Synovitis † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Nervous system disorders        
Cerebral haemorrhage † 1 [3]      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     0/1016 (0.00%)  
Headache † 1      
# participants affected / at risk     2/2288 (0.09%)     2/1206 (0.17%)     0/1016 (0.00%)  
Hypoaesthesia † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Neuralgia † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Psychiatric disorders        
Completed suicide † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Depression † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Disorientation † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Renal and urinary disorders        
Renal failure † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Renal failure acute † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Pulmonary oedema † 1 [4]      
# participants affected / at risk     2/2288 (0.09%)     0/1206 (0.00%)     1/1016 (0.10%)  
Skin and subcutaneous tissue disorders        
Toxic skin eruption † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Surgical and medical procedures        
Hospitalisation † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Thrombectomy † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Vascular disorders        
Deep vein thrombosis † 1      
# participants affected / at risk     1/2288 (0.04%)     0/1206 (0.00%)     1/1016 (0.10%)  
Venous thrombosis † 1      
# participants affected / at risk     1/2288 (0.04%)     1/1206 (0.08%)     0/1016 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.1
[3] Adverse event occurred in one of the 66 participants receiving both capsules and tablets, or oral solution.
[4] One of the two adverse events occurred in one of the 66 participants receiving both capsules and tablets, or oral solution.




  Other Adverse Events


  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: Abbott
phone: 1-800-633-9110


No publications provided


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