Drug Use Investigation of Kaletra

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01076972
First received: February 25, 2010
Last updated: January 31, 2012
Last verified: January 2012
Results First Received: December 9, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Human Immunodeficiency Virus
Intervention: Drug: Lopinavir/ritonavir (Kaletra)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lopinavir/Ritonavir Group All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Participant Flow:   Overall Study
    Lopinavir/Ritonavir Group  
STARTED     1184  
COMPLETED     1184  
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.
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Reporting Groups
  Description
Lopinavir/Ritonavir Group All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Baseline Measures
    Lopinavir/Ritonavir Group  
Number of Participants  
[units: participants]
  1184  
Age  
[units: years]
Mean ± Standard Deviation
  39.7  ± 11.0  
Age, Customized  
[units: participants]
 
<=14 years     4  
Between 15 and 64 years     1155  
>=65 years     25  
Gender  
[units: participants]
 
Female     106  
Male     1078  
Region of Enrollment  
[units: participants]
 
Japan     1184  



  Outcome Measures
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1.  Primary:   Total Number of Patients With Adverse Drug Reactions   [ Time Frame: During the course of the survey period up to Year 8 ]

Measure Type Primary
Measure Title Total Number of Patients With Adverse Drug Reactions
Measure Description Number of patients with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"), that occurred in ≥ 5% of patients. Adverse drug reactions are reported by preferred term and inclusive of all those reported at each visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.
Time Frame During the course of the survey period up to Year 8  
Safety Issue Yes  

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.
Available data for all patients were included.

Reporting Groups
  Description
Lopinavir/Ritonavir Group All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.

Measured Values
    Lopinavir/Ritonavir Group  
Number of Participants Analyzed  
[units: participants]
  1184  
Total Number of Patients With Adverse Drug Reactions  
[units: participants]
 
Any adverse drug reaction     649  
Hypertriglyceridaemia     67  
Hyperlipidaemia     211  
Diarrhoea     130  
Nausea     72  
Blood triglycerides increased     99  

No statistical analysis provided for Total Number of Patients With Adverse Drug Reactions



2.  Primary:   Cluster of Differentiation 4 Lymphocyte Count (CD4)   [ Time Frame: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period ]

Measure Type Primary
Measure Title Cluster of Differentiation 4 Lymphocyte Count (CD4)
Measure Description The evolution of patients' CD4-positive (CD4+) T-lymphocyte counts after starting treatment with Kaletra was assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ counts are reported as the number of CD4+ cells per cubic millimeter (cmm) and presented by the mean at each visit. Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of patients naive to previous antiretroviral treatment and those that were not who had CD4+ T-cell counts available for analysis at each study visit.
Time Frame Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period  
Safety Issue No  

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.
Available data at each visit for each subgroup of patients who had not received and received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline or treatment data were missing for a given visit were excluded from the analysis for that visit.

Reporting Groups
  Description
Lopinavir/Ritonavir: Treatment-Naive The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
Lopinavir/Ritonavir: Treatment-Experienced The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.

Measured Values
    Lopinavir/Ritonavir: Treatment-Naive     Lopinavir/Ritonavir: Treatment-Experienced  
Number of Participants Analyzed  
[units: participants]
  416     420  
Cluster of Differentiation 4 Lymphocyte Count (CD4)  
[units: cells per cubic millimeter]
Mean ± Standard Deviation
   
Baseline (Month 0 [n = 416, 420])     125.0  ± 123.5     290.6  ± 224.6  
Month 3 (n = 315, 283)     257.2  ± 170.8     342.9  ± 230.5  
Month 6 (n = 288, 252)     275.9  ± 175.4     366.4  ± 227.0  
Month 9 (n = 223, 238)     311.1  ± 175.1     385.0  ± 224.3  
Month 12 (Year 1 [n = 201, 233])     329.9  ± 178.6     410.4  ± 214.7  
Year 2 (n = 146, 190)     419.4  ± 201.1     437.4  ± 224.2  
Year 3 (n = 106, 150)     455.6  ± 202.4     481.5  ± 255.4  
Year 4 (n = 69, 99)     475.2  ± 209.6     526.6  ± 296.4  
Year 5 (n = 40, 73)     535.1  ± 248.0     496.2  ± 228.7  
Year 6 (n = 25, 42)     577.1  ± 241.9     569.7  ± 287.0  
Year 7 (n = 3, 17)     602.0  ± 156.1     597.7  ± 224.2  
Year 8 (n = 0, 3)     NA  ± NA [1]   493.7  ± 414.8  
[1] No data were recorded for any patients at this visit.

No statistical analysis provided for Cluster of Differentiation 4 Lymphocyte Count (CD4)



3.  Primary:   Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit   [ Time Frame: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period ]

Measure Type Primary
Measure Title Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit
Measure Description Number of HIV RNA copies per mL is presented by the mean per visit for patients that were naive to previous antiretroviral treatment and those that were not. HIV-RNA data reported as < 400 copies/mL were considered 399 copies/mL in calculations. The mean and standard deviation of HIV-RNA levels were thus calculated after logarithmic (base 10) transformation (log10 399 is 2.6). Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of treatment-naive, treatment-experienced participants who had CD4+ T-cell counts available for analysis at each study visit.
Time Frame Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period  
Safety Issue No  

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.
Available data at each visit for each subgroup of patients who had not received and who had received prior antiretroviral drug therapy were included in the analyses. Data for patients for whom either baseline data or treatment data were missing for a given visit were excluded from the analysis for that visit.

Reporting Groups
  Description
Lopinavir/Ritonavir: Treatment-Naive The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
Lopinavir/Ritonavir: Treatment-experienced The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 418 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.

Measured Values
    Lopinavir/Ritonavir: Treatment-Naive     Lopinavir/Ritonavir: Treatment-experienced  
Number of Participants Analyzed  
[units: participants]
  416     418  
Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit  
[units: copies/mL]
Mean ± Standard Deviation
   
Baseline (Month 0 [n = 416, 418])     4.9  ± 0.8     3.5  ± 1.1  
Month 3 (n = 315, 280)     2.7  ± 0.4     2.8  ± 0.5  
Month 6 (n = 288, 253)     2.7  ± 0.3     2.8  ± 0.6  
Month 9 (n = 224, 238)     2.6  ± 0.3     2.8  ± 0.5  
Month 12 (Year 1 [n = 203, 230])     2.7  ± 0.4     2.8  ± 0.6  
Year 2 (n = 145, 190)     2.7  ± 0.3     2.7  ± 0.5  
Year 3 (n = 107, 147)     2.6  ± 0.1     2.7  ± 0.4  
Year 4 (n = 70, 99)     2.6  ± 0.1     2.7  ± 0.4  
Year 5 (n = 39, 72)     2.7  ± 0.3     2.8  ± 0.5  
Year 6 (n = 25, 41)     2.7  ± 0.3     2.6  ± 0.3  
Year 7 (n = 3, 17)     2.6  ± 0.0     2.8  ± 0.6  
Year 8 (n = 0, 3)     NA  ± NA [1]   2.6  ± 0.0  
[1] No data were recorded for any patients at this visit.

No statistical analysis provided for Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit



4.  Primary:   Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents   [ Time Frame: Baseline (Month 0) and following last treatment dose during the course of the survey period ]

Measure Type Primary
Measure Title Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents
Measure Description Number of patients in each CDC category at Baseline (last assessment within 30 days prior to first dose of Kaletra) and after treatment. CDC categories defined as: Category A (asymptomatic acute HIV infection), Category B (symptomatic HIV infection; not Categories A and C), Category C (acquired immunodeficiency syndrome [AIDS] indicator status), Class P-0 (children not confirmed for HIV infection), Class P-1 (children with asymptomatic HIV infection), or Class P-2 (children with symptomatic HIV infection).
Time Frame Baseline (Month 0) and following last treatment dose during the course of the survey period  
Safety Issue No  

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.
Available data for all patients were included.

Reporting Groups
  Description
Lopinavir/Ritonavir: Baseline Category A The subgroup of patients who were classified as CDC Category A at Baseline (prior to treatment with lopinavir/ritonavir).
Lopinavir/Ritonavir: Baseline Category B The subgroup of participants who were classified as CDC Category B at Baseline (prior to treatment with lopinavir/ritonavir).
Lopinavir/Ritonavir: Baseline Category C The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).
Lopinavir/Ritonavir: Baseline Category P-0 The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).
Lopinavir/Ritonavir: Baseline Category P-1 The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).
Lopinavir/Ritonavir: Baseline Category P-2 The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).
Lopinavir/Ritonavir: Baseline Category Unknown The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.

Measured Values
    Lopinavir/Ritonavir: Baseline Category A     Lopinavir/Ritonavir: Baseline Category B     Lopinavir/Ritonavir: Baseline Category C     Lopinavir/Ritonavir: Baseline Category P-0     Lopinavir/Ritonavir: Baseline Category P-1     Lopinavir/Ritonavir: Baseline Category P-2     Lopinavir/Ritonavir: Baseline Category Unknown  
Number of Participants Analyzed  
[units: participants]
  378     71     323     0     0     1     411  
Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents  
[units: participants]
             
Category A after lopinavir/ritonavir treatment     206     0     0             0     103  
Category B after lopinavir/ritonavir treatment     2     32     0             0     22  
Category C after lopinavir/ritonavir treatment     6     2     191             0     86  
Category P-0 after lopinavir/ritonavir treatment     0     0     0             0     0  
Category P-1 after lopinavir/ritonavir treatment     0     0     0             0     1  
Category P-2 after lopinavir/ritonavir treatment     0     0     0             0     0  
Category unknown after treatment     164     37     132             1     199  

No statistical analysis provided for Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents




  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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