Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(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:
NCT00443729
First received: March 2, 2007
Last updated: September 1, 2015
Last verified: September 2015
Results First Received: October 12, 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: Comparator: raltegravir
Drug: Comparator: placebo
Drug: Comparator: lopinavir (+) ritonavir

  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

Phase III; First Patient In: 11-Jun-2007; Last Patient Last Visit for Week 24 (primary endpoint): 17-Oct-

2008

34 Sites (US, Peru, Brazil, Colombia, Mexico, South Africa, Thailand, India, 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   176   179 
Treated   176   178 
COMPLETED   166   172 
NOT COMPLETED   10   7 
Never Treated                0                1 
Lack of Efficacy                4                2 
Lost to Follow-up                0                1 
Physician Decision                2                1 
Protocol Violation                1                1 
Withdrawal by Subject                3                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 
Overall Participants Analyzed 
[Units: Participants]
 176   178   354 
Age 
[Units: Years]
Mean (Full Range)
 42.0 
 (21 to 71) 
 41.9 
 (23 to 74) 
 42.0 
 (21 to 74) 
Gender 
[Units: Participants]
     
Female   39   40   79 
Male   137   138   275 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   68   73   141 
Not Hispanic or Latino   108   105   213 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   1   1 
Asian   26   28   54 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   33   25   58 
White   85   81   166 
More than one race   32   42   74 
Unknown or Not Reported   0   0   0 
Cluster of Differentiation 4 (CD4) Cell Count 
[Units: Cells/mm3]
Mean (Full Range)
 470.8 
 (16 to 1916) 
 482.4 
 (100 to 1744) 
 476.6 
 (16 to 1916) 
Fasting (non-random) serum High-Density Lipoprotein-Cholesterol (HDL-C) 
[Units: mg/dL]
Mean (Standard Deviation)
 46.5  (12.8)   47.9  (12.7)   47.2  (12.7) 
Fasting (non-random) serum Low-Density Lipoprotein-Cholesterol (LDL-C) 
[Units: mg/dL]
Mean (Standard Deviation)
 103.5  (41.0)   104.3  (30.6)   103.9  (36.2) 
Fasting (non-random) serum cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
 214.7  (69.7)   210.8  (46.4)   212.7  (59.2) 
Fasting (non-random) serum triglyceride [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 204.5  (156.3)   217.5  (156.3)   212.5  (156.3) 
[1] Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Non-HDL-C 
[Units: mg/dL]
Mean (Standard Deviation)
 168.2  (71.8)   163.4  (45.7)   165.8  (60.3) 


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

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 24 Weeks  
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; one patient was 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. 
Participants Analyzed 
[Units: Participants]
 175   178 
Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24 
[Units: Participants]
 154   167 

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 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. 
Participants Analyzed 
[Units: Participants]
 176   178 
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks 
[Units: Participants]
   
With CAEs   123   112 
Without CAEs   53   66 

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. 
Participants Analyzed 
[Units: Participants]
 166   165 
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 
[Units: Percent Change]
Mean (Standard Deviation)
 -12.41  (15.80)   1.29  (15.81) 

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. 
Participants Analyzed 
[Units: Participants]
 166   162 
Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 
[Units: Percent Change]
Mean (Standard Deviation)
 -14.77  (18.78)   2.91  (20.26) 

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. 
Participants Analyzed 
[Units: Participants]
 161   162 
Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 
[Units: Percent Change]
Mean (Standard Deviation)
 3.99  (33.11)   0.55  (21.51) 

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. 
Participants Analyzed 
[Units: Participants]
 166   162 
Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12 
[Units: Percent Change]
Mean (Standard Deviation)
 -0.64  (20.14)   -2.50  (16.50) 

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. 
Participants Analyzed 
[Units: Participants]
 166   165 
Median Percent Change From Baseline in Serum Triglyceride at Week 12 
[Units: Percent Change]
Median (Standard Deviation)
 -42.82  (29.86)   8.20  (52.73) 

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. 
Participants Analyzed 
[Units: Participants]
 168   165 
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24 
[Units: Percent Change]
Mean (Standard Deviation)
 -13.64  (16.25)   3.55  (15.50) 

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. 
Participants Analyzed 
[Units: Participants]
 168   162 
Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 
[Units: Percent Change]
Mean (Standard Deviation)
 -15.83  (19.88)   5.26  (19.90) 

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. 
Participants Analyzed 
[Units: Participants]
 163   162 
Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 
[Units: Percent Change]
Mean (Standard Deviation)
 5.12  (35.65)   6.06  (26.22) 

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. 
Participants Analyzed 
[Units: Participants]
 168   162 
Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24 
[Units: Percent Change]
Mean (Standard Deviation)
 -1.77  (20.56)   -0.15  (16.62) 

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. 
Participants Analyzed 
[Units: Participants]
 168   165 
Median Percent Change From Baseline in Serum Triglyceride at Week 24 
[Units: Percent Change]
Median (Standard Deviation)
 -44.50  (33.26)   7.06  (55.42) 

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. 
Participants Analyzed 
[Units: Participants]
 176   178 
Number of Patients With Serious CAEs Through 24 Weeks 
[Units: Participants]
   
With Serious CAEs   4   8 
Without Serious CAEs   172   170 

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. 
Participants Analyzed 
[Units: Participants]
 176   178 
Number of Patients With Drug-related CAEs Through 24 Weeks 
[Units: Participants]
   
With drug-related CAEs   23   35 
Without drug-related CAEs   153   143 

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. 
Participants Analyzed 
[Units: Participants]
 176   178 
Number of Patients With Serious Drug-related CAEs Through 24 Weeks 
[Units: Participants]
   
With Serious drugrelated CAEs   0   0 
Without Serious drugrelated CAEs   176   178 

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. 
Participants Analyzed 
[Units: Participants]
 176   178 
Number of Patients That Died by 24 Week Last Patient Last Visit 
[Units: Participants]
   
Died   0   0 
Did Not Die   176   178 

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. 
Participants Analyzed 
[Units: Participants]
 176   178 
Number of Patients That Discontinued Due to CAEs Through 24 Weeks 
[Units: Participants]
   
Discontinued with CAEs   0   0 
Did Not Discontinue with CAEs   176   178 

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



18.  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 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. 
Participants Analyzed 
[Units: Participants]
 176   178 
Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks 
[Units: Participants]
   
With LAEs   8   6 
Without LAEs   168   172 

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



19.  Other Pre-specified:   Number of Patients 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 With Drug-related 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. 
Participants Analyzed 
[Units: Participants]
 176   178 
Number of Patients With Drug-related LAEs Through 24 Weeks 
[Units: Participants]
   
With LAEs   4   1 
Without LAEs   172   177 

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



20.  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. 
Participants Analyzed 
[Units: Participants]
 176   178 
Number of Patients With Serious LAEs Through 24 Weeks 
[Units: Participants]
   
With LAEs   0   0 
Without LAEs   176   178 

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



21.  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. 
Participants Analyzed 
[Units: Participants]
 176   178 
Number of Patients That Discontinued Due to LAEs Through 24 Weeks 
[Units: Participants]
   
Discontinued with LAEs   0   0 
Did Not Discontinue with LAEs   176   178 

No statistical analysis provided for Number of Patients That Discontinued Due to 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
Study was terminated after the primary efficacy analysis at Week 24 did not demonstrate non-inferiority of MK0518 versus KALETRA™.


  More Information