MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)

This study has been terminated.
(primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00443703
First received: March 2, 2007
Last updated: February 28, 2012
Last verified: February 2012
Results First Received: October 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HIV Infection
Interventions: Drug: MK0518 (raltegravir)
Drug: Comparator: KALETRA™ (lopinavir (+) ritonavir )
Drug: Comparator: placebo

  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

Phase III; First Patient In: 20-Jun-2007; Last Patient Last Visit for Week 24 (primary endpoint): 31-Oct-2008

47 Sites (US, Canada, Denmark, Germany, Italy, Portugal, Spain, United Kingdom, and Australia).


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
HIV-seropositive patients who were ≥18 years old, had documented HIV RNA <50 copies/mL for at least 3 months, had been on a KALETRA™-based regimen for at least 3 months without a change in background antiretroviral therapy, and had no documentation of HIV RNA >50 copies/mL for at least 3 months.

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Participant Flow:   Overall Study
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
STARTED     177     175  
Treated     174     174  
COMPLETED     149     157  
NOT COMPLETED     28     18  
Never Treated                 3                 1  
Adverse Event                 7                 3  
Lack of Efficacy                 3                 1  
Lost to Follow-up                 0                 4  
Physician Decision                 4                 2  
Protocol Violation                 1                 1  
Withdrawal by Subject                 9                 6  
Progressive Disease                 1                 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
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
Total Total of all reporting groups

Baseline Measures
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.     Total  
Number of Participants  
[units: participants]
  174     174     348  
Age  
[units: years]
Mean ( Full Range )
  44.4  
  ( 23 to 70 )  
  43.6  
  ( 24 to 71 )  
  44.0  
  ( 23 to 71 )  
Gender  
[units: participants]
     
Female     28     45     73  
Male     146     129     275  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     25     23     48  
Not Hispanic or Latino     149     151     300  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     2     3     5  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     24     28     52  
White     146     141     287  
More than one race     2     2     4  
Unknown or Not Reported     0     0     0  
Cluster of Differentiation 4 (CD4) Cell Count  
[units: cells/mm3]
Mean ( Full Range )
  477.6  
  ( 65 to 1446 )  
  508.2  
  ( 87 to 1510 )  
  492.9  
  ( 65 to 1510 )  
Fasting (non-random) serum High Density Lipoprotein-Cholesterol (HDL-C)  
[units: mg/dL]
Mean ± Standard Deviation
  48.8  ± 16.4     47.1  ± 14.0     47.9  ± 15.2  
Fasting (non-random) serum Low Density Lipoprotein-Cholesterol (LDL-C)  
[units: mg/dL]
Mean ± Standard Deviation
  115.3  ± 40.3     104.8  ± 35.9     110.0  ± 38.5  
Fasting (non-random) serum cholesterol  
[units: mg/dL]
Mean ± Standard Deviation
  215.3  ± 48.2     203.9  ± 52.3     209.6  ± 50.6  
Fasting (non-random) serum triglyceride [1]
[units: mg/dL]
Mean ± Standard Deviation
  189.5  ± 134.0     162.0  ± 112.6     175.0  ± 126.5  
Non-HDL-C  
[units: mg/dL]
Mean ± Standard Deviation
  165.5  ± 48.5     156.8  ± 53.0     161.1  ± 50.9  
[1] Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24   [ Time Frame: Week 24 ]

Measure Type Primary
Measure Title Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
Measure Description No text entered.
Time Frame Week 24  
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.
Full analysis set; two patients were excluded from the analysis because they did not have an HIV RNA test performed at Week 24 but had a test result of HIV RNA <50 copies/mL at Week 12 and Week 36.

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  172     174  
Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24  
[units: Participants]
  139     152  

No statistical analysis provided for Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24



2.  Primary:   Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Primary
Measure Title Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
Measure Description An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks  
[units: Participants]
   
With CAEs     109     106  
Without CAEs     65     68  

No statistical analysis provided for Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks



3.  Primary:   Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Primary
Measure Title Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
Measure Description No text entered.
Time Frame Baseline and Week 12  
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.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  142     146  
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12  
[units: Percent Change]
Mean ± Standard Deviation
  -12.83  ± 12.19     0.70  ± 14.69  

No statistical analysis provided for Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12



4.  Primary:   Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Primary
Measure Title Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Measure Description No text entered.
Time Frame Baseline and Week 12  
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.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  140     145  
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12  
[units: Percent Change]
Mean ± Standard Deviation
  -15.17  ± 15.80     2.31  ± 19.37  

No statistical analysis provided for Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12



5.  Primary:   Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Primary
Measure Title Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Measure Description No text entered.
Time Frame Baseline and Week 12  
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.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  134     135  
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12  
[units: Percent Change]
Mean ± Standard Deviation
  -2.43  ± 22.63     2.05  ± 29.87  

No statistical analysis provided for Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12



6.  Primary:   Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Primary
Measure Title Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
Measure Description No text entered.
Time Frame Baseline and Week 12  
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.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  140     145  
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12  
[units: Percent Change]
Mean ± Standard Deviation
  -0.86  ± 18.71     0.78  ± 25.38  

No statistical analysis provided for Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12



7.  Primary:   Median Percent Change From Baseline in Serum Triglyceride at Week 12   [ Time Frame: Baseline and Week 12 ]

Measure Type Primary
Measure Title Median Percent Change From Baseline in Serum Triglyceride at Week 12
Measure Description Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time Frame Baseline and Week 12  
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.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  142     146  
Median Percent Change From Baseline in Serum Triglyceride at Week 12  
[units: Percent Change]
Median ± Standard Deviation
  -41.50  ± 35.37     3.56  ± 59.36  

No statistical analysis provided for Median Percent Change From Baseline in Serum Triglyceride at Week 12



8.  Secondary:   Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24   [ Time Frame: Baseline and Week 24 ]

Measure Type Secondary
Measure Title Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24
Measure Description No text entered.
Time Frame Baseline and Week 24  
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.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  146     149  
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24  
[units: Percent Change]
Mean ± Standard Deviation
  -13.81  ± 12.02     2.70  ± 17.69  

No statistical analysis provided for Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24



9.  Secondary:   Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24   [ Time Frame: Baseline and Week 24 ]

Measure Type Secondary
Measure Title Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Measure Description No text entered.
Time Frame Baseline and Week 24  
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.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  143     148  
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24  
[units: Percent Change]
Mean ± Standard Deviation
  -15.03  ± 16.52     5.53  ± 21.96  

No statistical analysis provided for Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24



10.  Secondary:   Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24   [ Time Frame: Baseline and Week 24 ]

Measure Type Secondary
Measure Title Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
Measure Description No text entered.
Time Frame Baseline and Week 24  
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.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  139     143  
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24  
[units: Percent Change]
Mean ± Standard Deviation
  -1.12  ± 23.66     8.54  ± 27.44  

No statistical analysis provided for Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24



11.  Secondary:   Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24   [ Time Frame: Baseline and Week 24 ]

Measure Type Secondary
Measure Title Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
Measure Description No text entered.
Time Frame Baseline and Week 24  
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.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  143     148  
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24  
[units: Percent Change]
Mean ± Standard Deviation
  -4.42  ± 17.80     -1.70  ± 20.24  

No statistical analysis provided for Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24



12.  Secondary:   Median Percent Change From Baseline in Serum Triglyceride at Week 24   [ Time Frame: Baseline and Week 24 ]

Measure Type Secondary
Measure Title Median Percent Change From Baseline in Serum Triglyceride at Week 24
Measure Description Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time Frame Baseline and Week 24  
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.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  146     149  
Median Percent Change From Baseline in Serum Triglyceride at Week 24  
[units: Percent Change]
Median ± Standard Deviation
  -44.53  ± 31.43     6.14  ± 57.80  

No statistical analysis provided for Median Percent Change From Baseline in Serum Triglyceride at Week 24



13.  Other Pre-specified:   Number of Patients With Serious CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients With Serious CAEs Through 24 Weeks
Measure Description Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients With Serious CAEs Through 24 Weeks  
[units: participants]
   
With Serious CAEs     15     10  
Without Serious CAEs     159     164  

No statistical analysis provided for Number of Patients With Serious CAEs Through 24 Weeks



14.  Other Pre-specified:   Number of Patients With Drug-related CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients With Drug-related CAEs Through 24 Weeks
Measure Description Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients With Drug-related CAEs Through 24 Weeks  
[units: participants]
   
With drug-related CAEs     24     19  
Without drug-related CAEs     150     155  

No statistical analysis provided for Number of Patients With Drug-related CAEs Through 24 Weeks



15.  Other Pre-specified:   Number of Patients With Serious Drug-related CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients With Serious Drug-related CAEs Through 24 Weeks
Measure Description Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Drug-related are as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients With Serious Drug-related CAEs Through 24 Weeks  
[units: participants]
   
With Serious drug-related CAEs     0     0  
Without Serious drug-related CAEs     174     174  

No statistical analysis provided for Number of Patients With Serious Drug-related CAEs Through 24 Weeks



16.  Other Pre-specified:   Number of Patients That Died by 24 Week Last Patient Last Visit   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients That Died by 24 Week Last Patient Last Visit
Measure Description No text entered.
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients That Died by 24 Week Last Patient Last Visit  
[units: participants]
   
Died     0     0  
Did Not Die     174     174  

No statistical analysis provided for Number of Patients That Died by 24 Week Last Patient Last Visit



17.  Other Pre-specified:   Number of Patients That Discontinued Due to CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients That Discontinued Due to CAEs Through 24 Weeks
Measure Description No text entered.
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients That Discontinued Due to CAEs Through 24 Weeks  
[units: participants]
   
Discontinued with CAEs     4     4  
Did not Discontinue with CAEs     170     170  

No statistical analysis provided for Number of Patients That Discontinued Due to CAEs Through 24 Weeks



18.  Other Pre-specified:   Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks
Measure Description No text entered.
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks  
[units: participants]
   
Discontinued with drug related CAEs     2     3  
Did Not Discontinue with drug related CAEs     172     171  

No statistical analysis provided for Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks



19.  Other Pre-specified:   Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks
Measure Description A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks  
[units: participants]
   
With LAEs     11     7  
Without LAEs     163     167  

No statistical analysis provided for Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks



20.  Other Pre-specified:   Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks
Measure Description Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks  
[units: participants]
   
With LAEs     6     2  
Without LAEs     168     172  

No statistical analysis provided for Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks



21.  Other Pre-specified:   Number of Patients With Serious LAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients With Serious LAEs Through 24 Weeks
Measure Description Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients With Serious LAEs Through 24 Weeks  
[units: participants]
   
With LAEs     0     0  
Without LAEs     174     174  

No statistical analysis provided for Number of Patients With Serious LAEs Through 24 Weeks



22.  Other Pre-specified:   Number of Patients That Discontinued Due to LAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients That Discontinued Due to LAEs Through 24 Weeks
Measure Description No text entered.
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients That Discontinued Due to LAEs Through 24 Weeks  
[units: participants]
   
Discontinued with LAEs     2     1  
Did Not Discontinue with LAEs     172     173  

No statistical analysis provided for Number of Patients That Discontinued Due to LAEs Through 24 Weeks



23.  Other Pre-specified:   Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Measure Type Other Pre-specified
Measure Title Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks
Measure Description Number of patients that discontinued with drug-related (as assessed by an investigator who is a qualified physician, according to his or her clinical judgement) LAEs.
Time Frame 24 Week last patient last visit  
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.
All patients who took study medication were included in the analysis

Reporting Groups
  Description
MK0518 400 mg b.i.d. MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
KALETRA™ 400/100 mg b.i.d. KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food

Measured Values
    MK0518 400 mg b.i.d.     KALETRA™ 400/100 mg b.i.d.  
Number of Participants Analyzed  
[units: participants]
  174     174  
Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks  
[units: participants]
   
Discontinued with Drug Related LAEs     2     1  
Did Not Discontinue with Drug Related LAEs     172     173  

No statistical analysis provided for Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks




  Serious Adverse Events


  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
The reason for early termination: Study was terminated after the primary efficacy analysis at Week 24 did not demonstrate non-inferiority of MK0518 versus KALETRA™.


  More Information