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Surveillance of Kaletra in Korean Patients

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ClinicalTrials.gov Identifier: NCT01083173
Recruitment Status : Completed
First Posted : March 9, 2010
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition HIV-1 Infection
Enrollment 595

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Main Surveillance Long-term Surveillance
Hide Arm/Group Description The safety population included all participants who received at least one dose of Kaletra, and the effectiveness population included all participants who received Kaletra treatment for at least 24 weeks. The safety population included all participants who received Kaletra for more than 24 weeks, and the effectiveness population included all participants who received Kaletra treatment for at least 48 weeks.
Period Title: Main Surveillance: Safety Group
Started 595 0
Completed 580 0
Not Completed 15 0
Reason Not Completed
Violation of inclusion/exclusion crit.             14             0
Violation of the use/dosage             1             0
Period Title: Main Surveillance: Effectiveness Group
Started 580 0
Completed 198 0
Not Completed 382 0
Reason Not Completed
No follow-up at 24 ±4 wks             201             0
No viral load data at 24 ±4 wks             168             0
Administration of Kaletra <24 wks             13             0
Period Title: Long-term Surveillance: Safety Group
Started 0 595
Completed 0 479
Not Completed 0 116
Reason Not Completed
Violation of inclusion/exclusion crit.             0             14
Violation of the dosage             0             1
Administration of Kaletra <20 wks             0             101
Period Title: Long-term Surveillance: Effectiveness Gr
Started 0 479
Completed 0 102
Not Completed 0 377
Reason Not Completed
No follow-up at 48 ±4 wks             0             195
No viral load data at 48 ±4 wks             0             136
Administration of Kaletra <48 wks             0             46
Arm/Group Title Overall Study
Hide Arm/Group Description The main surveillance safety population included all participants who received at least one dose of Kaletra. The long-term surveillance safety population included participants who received Kaletra for more than 24 weeks.
Overall Number of Baseline Participants 580
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 580 participants
Main Surveillance n= 580 41.3  (12.5)
Long-term Surveillance n=479 41  (12.1)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 580 participants
Main Surveillance Females 56
Main Surveillance Males 524
Long-Term Surveillance Females 47
Long-Term Surveillance Males 432
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose.
Time Frame From the start of treatment until 30 days after the last dose, up to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Main Surveillance Long-term Surveillance
Hide Arm/Group Description:
All participants who received at least one dose of Kaletra
Participants who received Kaletra for more than 24 weeks
Overall Number of Participants Analyzed 580 479
Measure Type: Number
Unit of Measure: participants
363 285
2.Primary Outcome
Title Number of Participants Who Interrupted or Discontinued Kaletra Treatment
Hide Description At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc).
Time Frame Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Main Surveillance Long-term Surveillance
Hide Arm/Group Description:
All participants who received at least one dose of Kaletra
Participants who received Kaletra for more than 24 weeks
Overall Number of Participants Analyzed 580 479
Measure Type: Number
Unit of Measure: participants
120 43
3.Primary Outcome
Title Percentage of Participants With Viral Load Below 400 Copies/mL
Hide Description Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Main Surveillance
Hide Arm/Group Description:
All participants who received Kaletra treatment for at least 24 weeks
Overall Number of Participants Analyzed 198
Measure Type: Number
Unit of Measure: percentage of participants
92.4
4.Primary Outcome
Title Percentage of Participants With Viral Load Below 50 Copies/mL
Hide Description Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Long-term Surveillance
Hide Arm/Group Description:
All participants who received Kaletra treatment for at least 48 weeks
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of participants
68.6
5.Secondary Outcome
Title Change From Baseline in Viral Load
Hide Description This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated.
Time Frame Week 24 & 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Main Surveillance Long-term Surveillance
Hide Arm/Group Description:
All participants who received at least one dose of Kaletra
Participants who received Kaletra for more than 24 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts
Hide Description Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks.
Time Frame From baseline to Weeks 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Main Surveillance Long-term Surveillance
Hide Arm/Group Description:
All participants who received Kaletra treatment for at least 24 weeks
All participants who received Kaletra treatment for at least 48 weeks
Overall Number of Participants Analyzed 181 93
Mean (Standard Deviation)
Unit of Measure: cells/mm˄3
145.47  (144.28) 170.47  (159.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Main Surveillance
Comments CD4 cell counts at 24 weeks as compared to baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Long-term Surveillance
Comments CD4 cell counts at 48 weeks as compared to baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Confirmed Viral Resistance
Hide Description Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance.
Time Frame From baseline through weeks 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Main Surveillance Long-term Surveillance
Hide Arm/Group Description:
All participants who received Kaletra treatment for at least 24 weeks
All participants who received Kaletra treatment for at least 48 weeks
Overall Number of Participants Analyzed 198 102
Measure Type: Number
Unit of Measure: percentage of participants
0.51 1.96
8.Secondary Outcome
Title Mean Time to Treatment Failure
Hide Description Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level > 400 copies/mL at week 24 and HIV RNA level > 50 copies/mL at week 48.
Time Frame From baseline through weeks 24 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Main Surveillance Long-term Surveillance
Hide Arm/Group Description:
All participants who received Kaletra treatment for at least 24 weeks
All participants who received Kaletra treatment for at least 48 weeks
Overall Number of Participants Analyzed 198 102
Mean (Standard Error)
Unit of Measure: days
399.97  (3.45) 410.8  (1.03)
Time Frame From the start of treatment until 30 days after the last dose, up to 52 weeks
Adverse Event Reporting Description Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator’s view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
 
Arm/Group Title Main Surveillance Long-term Surveillance
Hide Arm/Group Description All participants who received at least one dose of Kaletra Participants who received Kaletra for more than 24 weeks
All-Cause Mortality
Main Surveillance Long-term Surveillance
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Main Surveillance Long-term Surveillance
Affected / at Risk (%) Affected / at Risk (%)
Total   51/580 (8.79%)   39/479 (8.14%) 
Blood and lymphatic system disorders     
Anaemia  1  5/580 (0.86%)  5/479 (1.04%) 
Neutropenia  1  2/580 (0.34%)  2/479 (0.42%) 
Bone marrow failure  1  3/580 (0.52%)  3/479 (0.63%) 
Pancytopenia  1  2/580 (0.34%)  0/479 (0.00%) 
Lymphadenitis  1  1/580 (0.17%)  1/479 (0.21%) 
Cardiac disorders     
Acute myocardial infarction  1  1/580 (0.17%)  1/479 (0.21%) 
Eye disorders     
Retinal detachment  1  1/580 (0.17%)  1/479 (0.21%) 
Retinal haemorrhage  1  1/580 (0.17%)  1/479 (0.21%) 
Gastrointestinal disorders     
Diarrhoea  1  1/580 (0.17%)  1/479 (0.21%) 
Nausea  1  2/580 (0.34%)  1/479 (0.21%) 
Vomiting  1  1/580 (0.17%)  0/479 (0.00%) 
General disorders     
Asthenia  1  2/580 (0.34%)  2/479 (0.42%) 
Chest discomfort  1  1/580 (0.17%)  0/479 (0.00%) 
Hepatobiliary disorders     
Hepatic cirrhosis  1  1/580 (0.17%)  1/479 (0.21%) 
Hepatic failure  1  1/580 (0.17%)  1/479 (0.21%) 
Liver disorder  1  1/580 (0.17%)  0/479 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  1/580 (0.17%)  1/479 (0.21%) 
Infections and infestations     
Herpes zoster  1  5/580 (0.86%)  5/479 (1.04%) 
Pneumocystis jirovecii pneumonia  1  8/580 (1.38%)  5/479 (1.04%) 
Cytomegalovirus chorioretinitis  1  1/580 (0.17%)  1/479 (0.21%) 
Pneumonia  1  4/580 (0.69%)  3/479 (0.63%) 
Progressive multifocal leukoencephalopathy  1  2/580 (0.34%)  1/479 (0.21%) 
Disseminated tuberculosis  1  1/580 (0.17%)  1/479 (0.21%) 
Pneumonia bacterial  1  2/580 (0.34%)  2/479 (0.42%) 
Arthritis bacterial  1  1/580 (0.17%)  1/479 (0.21%) 
Gastroenteritis  1  1/580 (0.17%)  1/479 (0.21%) 
Lobar pneumonia  1  1/580 (0.17%)  1/479 (0.21%) 
Mycobacterial infection  1  1/580 (0.17%)  0/479 (0.00%) 
Pneumonia cytomegaloviral  1  1/580 (0.17%)  0/479 (0.00%) 
Sepsis  1  1/580 (0.17%)  1/479 (0.21%) 
Septic shock  1  1/580 (0.17%)  1/479 (0.21%) 
Spleen tuberculosis  1  1/580 (0.17%)  1/479 (0.21%) 
Injury, poisoning and procedural complications     
Radius fracture  1  1/580 (0.17%)  1/479 (0.21%) 
Investigations     
Blood triglycerides increased  1  1/580 (0.17%)  0/479 (0.00%) 
Blood pressure decreased  1  1/580 (0.17%)  0/479 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/580 (0.17%)  1/479 (0.21%) 
Hyponatraemia  1  1/580 (0.17%)  1/479 (0.21%) 
Dehydration  1  1/580 (0.17%)  1/479 (0.21%) 
Electrolyte imbalance  1  1/580 (0.17%)  1/479 (0.21%) 
Hyperkalaemia  1  1/580 (0.17%)  1/479 (0.21%) 
Malnutrition  1  1/580 (0.17%)  0/479 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Diffuse large B-cell lymphoma  1  1/580 (0.17%)  1/479 (0.21%) 
Kaposi's sarcoma  1  1/580 (0.17%)  0/479 (0.00%) 
Lung neoplasm malignant  1  1/580 (0.17%)  1/479 (0.21%) 
Nervous system disorders     
Cerebral infarction  1  1/580 (0.17%)  1/479 (0.21%) 
Convulsion  1  1/580 (0.17%)  1/479 (0.21%) 
Dizziness  1  1/580 (0.17%)  0/479 (0.00%) 
Encephalopathy  1  1/580 (0.17%)  0/479 (0.00%) 
Syncope  1  1/580 (0.17%)  0/479 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Premature labour  1  2/580 (0.34%)  2/479 (0.42%) 
Psychiatric disorders     
Depression  1  1/580 (0.17%)  1/479 (0.21%) 
Renal and urinary disorders     
Renal failure acute  1  2/580 (0.34%)  1/479 (0.21%) 
Renal failure  1  1/580 (0.17%)  1/479 (0.21%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  1/580 (0.17%)  0/479 (0.00%) 
Respiratory failure  1  1/580 (0.17%)  0/479 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash generalised  1  1/580 (0.17%)  1/479 (0.21%) 
Vascular disorders     
Hypotension  1  1/580 (0.17%)  1/479 (0.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Main Surveillance Long-term Surveillance
Affected / at Risk (%) Affected / at Risk (%)
Total   222/580 (38.28%)   169/479 (35.28%) 
Gastrointestinal disorders     
Diarrhoea  1  119/580 (20.52%)  88/479 (18.37%) 
Nausea  1  70/580 (12.07%)  49/479 (10.23%) 
Infections and infestations     
Nasopharyngitis  1  33/580 (5.69%)  32/479 (6.68%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Information
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01083173     History of Changes
Other Study ID Numbers: P11-068
First Submitted: February 19, 2010
First Posted: March 9, 2010
Results First Submitted: October 30, 2015
Results First Posted: February 22, 2016
Last Update Posted: February 22, 2016