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MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED)

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ClinicalTrials.gov Identifier: NCT00443729
Recruitment Status : Terminated (Primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir)
First Posted : March 6, 2007
Results First Posted : November 19, 2009
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV Infection
Interventions Drug: Comparator: raltegravir
Drug: Comparator: placebo
Drug: Comparator: lopinavir (+) ritonavir
Enrollment 355
Recruitment Details

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 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.
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description 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, 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
Period Title: Overall Study
Started 176 179
Treated 176 178
Completed 166 172
Not Completed 10 7
Reason Not Completed
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
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d. Total
Hide Arm/Group Description 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, 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 of all reporting groups
Overall Number of Baseline Participants 176 178 354
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 176 participants 178 participants 354 participants
42.0
(21 to 71)
41.9
(23 to 74)
42.0
(21 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 178 participants 354 participants
Female
39
  22.2%
40
  22.5%
79
  22.3%
Male
137
  77.8%
138
  77.5%
275
  77.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 178 participants 354 participants
Hispanic or Latino
68
  38.6%
73
  41.0%
141
  39.8%
Not Hispanic or Latino
108
  61.4%
105
  59.0%
213
  60.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 178 participants 354 participants
American Indian or Alaska Native
0
   0.0%
1
   0.6%
1
   0.3%
Asian
26
  14.8%
28
  15.7%
54
  15.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.6%
1
   0.3%
Black or African American
33
  18.8%
25
  14.0%
58
  16.4%
White
85
  48.3%
81
  45.5%
166
  46.9%
More than one race
32
  18.2%
42
  23.6%
74
  20.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Cluster of Differentiation 4 (CD4) Cell Count  
Mean (Full Range)
Unit of measure:  Cells/mm3
Number Analyzed 176 participants 178 participants 354 participants
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)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 176 participants 178 participants 354 participants
46.5  (12.8) 47.9  (12.7) 47.2  (12.7)
Fasting (non-random) serum Low-Density Lipoprotein-Cholesterol (LDL-C)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 176 participants 178 participants 354 participants
103.5  (41.0) 104.3  (30.6) 103.9  (36.2)
Fasting (non-random) serum cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 176 participants 178 participants 354 participants
214.7  (69.7) 210.8  (46.4) 212.7  (59.2)
Fasting (non-random) serum triglyceride   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 176 participants 178 participants 354 participants
204.5  (156.3) 217.5  (156.3) 212.5  (156.3)
[1]
Measure Description: Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Non-HDL-C  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 176 participants 178 participants 354 participants
168.2  (71.8) 163.4  (45.7) 165.8  (60.3)
1.Primary Outcome
Title Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
Hide Description [Not Specified]
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 175 178
Measure Type: Number
Unit of Measure: Participants
154 167
2.Primary Outcome
Title Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
Hide Description [Not Specified]
Time Frame 24 Week last patient last visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 176 178
Measure Type: Number
Unit of Measure: Participants
With CAEs 123 112
Without CAEs 53 66
3.Primary Outcome
Title Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 166 165
Mean (Standard Deviation)
Unit of Measure: Percent Change
-12.41  (15.80) 1.29  (15.81)
4.Primary Outcome
Title Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 166 162
Mean (Standard Deviation)
Unit of Measure: Percent Change
-14.77  (18.78) 2.91  (20.26)
5.Primary Outcome
Title Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 161 162
Mean (Standard Deviation)
Unit of Measure: Percent Change
3.99  (33.11) 0.55  (21.51)
6.Primary Outcome
Title Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 166 162
Mean (Standard Deviation)
Unit of Measure: Percent Change
-0.64  (20.14) -2.50  (16.50)
7.Primary Outcome
Title Median Percent Change From Baseline in Serum Triglyceride at Week 12
Hide Description Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 166 165
Median (Standard Deviation)
Unit of Measure: Percent Change
-42.82  (29.86) 8.20  (52.73)
8.Secondary Outcome
Title Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 168 165
Mean (Standard Deviation)
Unit of Measure: Percent Change
-13.64  (16.25) 3.55  (15.50)
9.Secondary Outcome
Title Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 168 162
Mean (Standard Deviation)
Unit of Measure: Percent Change
-15.83  (19.88) 5.26  (19.90)
10.Secondary Outcome
Title Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 163 162
Mean (Standard Deviation)
Unit of Measure: Percent Change
5.12  (35.65) 6.06  (26.22)
11.Secondary Outcome
Title Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 168 162
Mean (Standard Deviation)
Unit of Measure: Percent Change
-1.77  (20.56) -0.15  (16.62)
12.Secondary Outcome
Title Median Percent Change From Baseline in Serum Triglyceride at Week 24
Hide Description Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 168 165
Median (Standard Deviation)
Unit of Measure: Percent Change
-44.50  (33.26) 7.06  (55.42)
13.Other Pre-specified Outcome
Title Number of Patients With Serious CAEs Through 24 Weeks
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 176 178
Measure Type: Number
Unit of Measure: Participants
With Serious CAEs 4 8
Without Serious CAEs 172 170
14.Other Pre-specified Outcome
Title Number of Patients With Drug-related CAEs Through 24 Weeks
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 176 178
Measure Type: Number
Unit of Measure: Participants
With drug-related CAEs 23 35
Without drug-related CAEs 153 143
15.Other Pre-specified Outcome
Title Number of Patients With Serious Drug-related CAEs Through 24 Weeks
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 176 178
Measure Type: Number
Unit of Measure: Participants
With Serious drugrelated CAEs 0 0
Without Serious drugrelated CAEs 176 178
16.Other Pre-specified Outcome
Title Number of Patients That Died by 24 Week Last Patient Last Visit
Hide Description [Not Specified]
Time Frame 24 Week last patient last visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 176 178
Measure Type: Number
Unit of Measure: Participants
Died 0 0
Did Not Die 176 178
17.Other Pre-specified Outcome
Title Number of Patients That Discontinued Due to CAEs Through 24 Weeks
Hide Description [Not Specified]
Time Frame 24 Week last patient last visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 176 178
Measure Type: Number
Unit of Measure: Participants
Discontinued with CAEs 0 0
Did Not Discontinue with CAEs 176 178
18.Other Pre-specified Outcome
Title Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks
Hide Description [Not Specified]
Time Frame 24 Week last patient last visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 176 178
Measure Type: Number
Unit of Measure: Participants
With LAEs 8 6
Without LAEs 168 172
19.Other Pre-specified Outcome
Title Number of Patients With Drug-related LAEs Through 24 Weeks
Hide Description [Not Specified]
Time Frame 24 Week last patient last visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 176 178
Measure Type: Number
Unit of Measure: Participants
With LAEs 4 1
Without LAEs 172 177
20.Other Pre-specified Outcome
Title Number of Patients With Serious LAEs Through 24 Weeks
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 176 178
Measure Type: Number
Unit of Measure: Participants
With LAEs 0 0
Without LAEs 176 178
21.Other Pre-specified Outcome
Title Number of Patients That Discontinued Due to LAEs Through 24 Weeks
Hide Description [Not Specified]
Time Frame 24 Week last patient last visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients who took study medication were included in the analysis
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description:
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, 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
Overall Number of Participants Analyzed 176 178
Measure Type: Number
Unit of Measure: Participants
Discontinued with LAEs 0 0
Did Not Discontinue with LAEs 176 178
Time Frame Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Hide Arm/Group Description 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, 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
All-Cause Mortality
MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Affected / at Risk (%) Affected / at Risk (%)
Total   4/176 (2.27%)   8/178 (4.49%) 
Cardiac disorders     
Coronary artery occlusion   0/176 (0.00%)  1/178 (0.56%) 
Gastrointestinal disorders     
Diarrhoea   1/176 (0.57%)  0/178 (0.00%) 
Gastritis   1/176 (0.57%)  0/178 (0.00%) 
Nausea   0/176 (0.00%)  1/178 (0.56%) 
Peptic ulcer   0/176 (0.00%)  1/178 (0.56%) 
Vomiting   0/176 (0.00%)  1/178 (0.56%) 
General disorders     
Pyrexia   0/176 (0.00%)  2/178 (1.12%) 
Infections and infestations     
Appendicitis   1/176 (0.57%)  0/178 (0.00%) 
Urinary tract infection   0/176 (0.00%)  1/178 (0.56%) 
Injury, poisoning and procedural complications     
Tendon rupture   0/176 (0.00%)  1/178 (0.56%) 
Metabolism and nutrition disorders     
Dehydration   0/176 (0.00%)  1/178 (0.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hodgkin's disease   1/176 (0.57%)  0/178 (0.00%) 
Kaposi's sarcoma AIDS related   1/176 (0.57%)  1/178 (0.56%) 
Lung neoplasm malignant   1/176 (0.57%)  0/178 (0.00%) 
Reproductive system and breast disorders     
Menstruation irregular   0/176 (0.00%)  1/178 (0.56%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
MK0518 400 mg b.i.d. KALETRA™ 400/100 mg b.i.d.
Affected / at Risk (%) Affected / at Risk (%)
Total   94/176 (53.41%)   84/178 (47.19%) 
Gastrointestinal disorders     
Abdominal distension   4/176 (2.27%)  6/178 (3.37%) 
Abdominal pain   4/176 (2.27%)  3/178 (1.69%) 
Abdominal pain upper   4/176 (2.27%)  2/178 (1.12%) 
Constipation   4/176 (2.27%)  1/178 (0.56%) 
Diarrhoea   7/176 (3.98%)  29/178 (16.29%) 
Dry mouth   4/176 (2.27%)  0/178 (0.00%) 
Flatulence   2/176 (1.14%)  6/178 (3.37%) 
Gastritis   6/176 (3.41%)  2/178 (1.12%) 
Nausea   6/176 (3.41%)  9/178 (5.06%) 
Vomiting   1/176 (0.57%)  4/178 (2.25%) 
General disorders     
Fatigue   5/176 (2.84%)  6/178 (3.37%) 
Pyrexia   5/176 (2.84%)  5/178 (2.81%) 
Infections and infestations     
Gastroenteritis   2/176 (1.14%)  6/178 (3.37%) 
Genital herpes   4/176 (2.27%)  2/178 (1.12%) 
Influenza   7/176 (3.98%)  6/178 (3.37%) 
Nasopharyngitis   5/176 (2.84%)  6/178 (3.37%) 
Pharyngitis   5/176 (2.84%)  2/178 (1.12%) 
Respiratory tract infection   4/176 (2.27%)  4/178 (2.25%) 
Sinusitis   4/176 (2.27%)  4/178 (2.25%) 
Upper respiratory tract infection   16/176 (9.09%)  15/178 (8.43%) 
Investigations     
Alanine aminotransferase increased   5/176 (2.84%)  3/178 (1.69%) 
Metabolism and nutrition disorders     
Hypertriglyceridaemia   1/176 (0.57%)  6/178 (3.37%) 
Musculoskeletal and connective tissue disorders     
Back pain   6/176 (3.41%)  1/178 (0.56%) 
Nervous system disorders     
Dizziness   3/176 (1.70%)  7/178 (3.93%) 
Headache   13/176 (7.39%)  7/178 (3.93%) 
Paraesthesia   3/176 (1.70%)  4/178 (2.25%) 
Psychiatric disorders     
Depression   7/176 (3.98%)  5/178 (2.81%) 
Insomnia   6/176 (3.41%)  7/178 (3.93%) 
Respiratory, thoracic and mediastinal disorders     
Cough   4/176 (2.27%)  3/178 (1.69%) 
Pharyngolaryngeal pain   4/176 (2.27%)  2/178 (1.12%) 
Skin and subcutaneous tissue disorders     
Rash   5/176 (2.84%)  5/178 (2.81%) 
Vascular disorders     
Hypertension   5/176 (2.84%)  2/178 (1.12%) 
Indicates events were collected by systematic assessment
Study was terminated after the primary efficacy analysis at Week 24 did not demonstrate non-inferiority of MK0518 versus KALETRA™.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00443729     History of Changes
Other Study ID Numbers: 0518-033
2007_508
First Submitted: March 2, 2007
First Posted: March 6, 2007
Results First Submitted: October 12, 2009
Results First Posted: November 19, 2009
Last Update Posted: March 21, 2017