Trial Outcomes & Findings for MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED) (NCT NCT00443703)
NCT ID: NCT00443703
Last Updated: 2017-03-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
352 participants
Primary outcome timeframe
Week 24
Results posted on
2017-03-21
Participant Flow
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).
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
175
|
|
Overall Study
Treated
|
174
|
174
|
|
Overall Study
COMPLETED
|
149
|
157
|
|
Overall Study
NOT COMPLETED
|
28
|
18
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Never Treated
|
3
|
1
|
|
Overall Study
Adverse Event
|
7
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Physician Decision
|
4
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
|
Overall Study
Progressive Disease
|
1
|
0
|
Baseline Characteristics
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)
Baseline characteristics by cohort
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.4 years
n=5 Participants
|
43.6 years
n=7 Participants
|
44.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
149 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
146 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
287 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Cluster of Differentiation 4 (CD4) Cell Count
|
477.6 cells/mm3
n=5 Participants
|
508.2 cells/mm3
n=7 Participants
|
492.9 cells/mm3
n=5 Participants
|
|
Fasting (non-random) serum High Density Lipoprotein-Cholesterol (HDL-C)
|
48.8 mg/dL
STANDARD_DEVIATION 16.4 • n=5 Participants
|
47.1 mg/dL
STANDARD_DEVIATION 14.0 • n=7 Participants
|
47.9 mg/dL
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Fasting (non-random) serum Low Density Lipoprotein-Cholesterol (LDL-C)
|
115.3 mg/dL
STANDARD_DEVIATION 40.3 • n=5 Participants
|
104.8 mg/dL
STANDARD_DEVIATION 35.9 • n=7 Participants
|
110.0 mg/dL
STANDARD_DEVIATION 38.5 • n=5 Participants
|
|
Fasting (non-random) serum cholesterol
|
215.3 mg/dL
STANDARD_DEVIATION 48.2 • n=5 Participants
|
203.9 mg/dL
STANDARD_DEVIATION 52.3 • n=7 Participants
|
209.6 mg/dL
STANDARD_DEVIATION 50.6 • n=5 Participants
|
|
Fasting (non-random) serum triglyceride
|
189.5 mg/dL
STANDARD_DEVIATION 134.0 • n=5 Participants
|
162.0 mg/dL
STANDARD_DEVIATION 112.6 • n=7 Participants
|
175.0 mg/dL
STANDARD_DEVIATION 126.5 • n=5 Participants
|
|
Non-HDL-C
|
165.5 mg/dL
STANDARD_DEVIATION 48.5 • n=5 Participants
|
156.8 mg/dL
STANDARD_DEVIATION 53.0 • n=7 Participants
|
161.1 mg/dL
STANDARD_DEVIATION 50.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: 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.
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=172 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
|
139 Participants
|
152 Participants
|
PRIMARY outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
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
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
With CAEs
|
109 Participants
|
106 Participants
|
|
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
Without CAEs
|
65 Participants
|
68 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=142 Participants
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.
n=146 Participants
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
|
|---|---|---|
|
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
|
-12.83 Percent Change
Standard Deviation 12.19
|
0.70 Percent Change
Standard Deviation 14.69
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=140 Participants
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.
n=145 Participants
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
|
|---|---|---|
|
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
|
-15.17 Percent Change
Standard Deviation 15.80
|
2.31 Percent Change
Standard Deviation 19.37
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=134 Participants
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.
n=135 Participants
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
|
|---|---|---|
|
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
-2.43 Percent Change
Standard Deviation 22.63
|
2.05 Percent Change
Standard Deviation 29.87
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=140 Participants
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.
n=145 Participants
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
|
|---|---|---|
|
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
|
-0.86 Percent Change
Standard Deviation 18.71
|
0.78 Percent Change
Standard Deviation 25.38
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=142 Participants
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.
n=146 Participants
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
|
|---|---|---|
|
Median Percent Change From Baseline in Serum Triglyceride at Week 12
|
-41.50 Percent Change
Standard Deviation 35.37
|
3.56 Percent Change
Standard Deviation 59.36
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=146 Participants
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.
n=149 Participants
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
|
|---|---|---|
|
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24
|
-13.81 Percent Change
Standard Deviation 12.02
|
2.70 Percent Change
Standard Deviation 17.69
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=143 Participants
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.
n=148 Participants
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
|
|---|---|---|
|
Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
|
-15.03 Percent Change
Standard Deviation 16.52
|
5.53 Percent Change
Standard Deviation 21.96
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=139 Participants
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.
n=143 Participants
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
|
|---|---|---|
|
Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
|
-1.12 Percent Change
Standard Deviation 23.66
|
8.54 Percent Change
Standard Deviation 27.44
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=143 Participants
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.
n=148 Participants
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
|
|---|---|---|
|
Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
|
-4.42 Percent Change
Standard Deviation 17.80
|
-1.70 Percent Change
Standard Deviation 20.24
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=146 Participants
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.
n=149 Participants
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
|
|---|---|---|
|
Median Percent Change From Baseline in Serum Triglyceride at Week 24
|
-44.53 Percent Change
Standard Deviation 31.43
|
6.14 Percent Change
Standard Deviation 57.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
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
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients With Serious CAEs Through 24 Weeks
With Serious CAEs
|
15 participants
|
10 participants
|
|
Number of Patients With Serious CAEs Through 24 Weeks
Without Serious CAEs
|
159 participants
|
164 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs.
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients With Drug-related CAEs Through 24 Weeks
With drug-related CAEs
|
24 participants
|
19 participants
|
|
Number of Patients With Drug-related CAEs Through 24 Weeks
Without drug-related CAEs
|
150 participants
|
155 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
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
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients With Serious Drug-related CAEs Through 24 Weeks
With Serious drug-related CAEs
|
0 participants
|
0 participants
|
|
Number of Patients With Serious Drug-related CAEs Through 24 Weeks
Without Serious drug-related CAEs
|
174 participants
|
174 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients That Died by 24 Week Last Patient Last Visit
Died
|
0 participants
|
0 participants
|
|
Number of Patients That Died by 24 Week Last Patient Last Visit
Did Not Die
|
174 participants
|
174 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients That Discontinued Due to CAEs Through 24 Weeks
Discontinued with CAEs
|
4 participants
|
4 participants
|
|
Number of Patients That Discontinued Due to CAEs Through 24 Weeks
Did not Discontinue with CAEs
|
170 participants
|
170 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks
Discontinued with drug related CAEs
|
2 participants
|
3 participants
|
|
Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks
Did Not Discontinue with drug related CAEs
|
172 participants
|
171 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
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
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks
With LAEs
|
11 participants
|
7 participants
|
|
Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks
Without LAEs
|
163 participants
|
167 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) LAEs
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks
With LAEs
|
6 participants
|
2 participants
|
|
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks
Without LAEs
|
168 participants
|
172 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
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
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients With Serious LAEs Through 24 Weeks
With LAEs
|
0 participants
|
0 participants
|
|
Number of Patients With Serious LAEs Through 24 Weeks
Without LAEs
|
174 participants
|
174 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients That Discontinued Due to LAEs Through 24 Weeks
Discontinued with LAEs
|
2 participants
|
1 participants
|
|
Number of Patients That Discontinued Due to LAEs Through 24 Weeks
Did Not Discontinue with LAEs
|
172 participants
|
173 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 Week last patient last visitPopulation: All patients who took study medication were included in the analysis
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.
Outcome measures
| Measure |
MK0518 400 mg b.i.d.
n=174 Participants
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.
n=174 Participants
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
|
|---|---|---|
|
Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks
Discontinued with Drug Related LAEs
|
2 participants
|
1 participants
|
|
Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks
Did Not Discontinue with Drug Related LAEs
|
172 participants
|
173 participants
|
Adverse Events
MK0518 400 mg b.i.d.
Serious events: 15 serious events
Other events: 76 other events
Deaths: 0 deaths
KALETRA™ 400/100 mg b.i.d.
Serious events: 10 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK0518 400 mg b.i.d.
n=174 participants at risk
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.
n=174 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Abdominal abscess
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Cellulitis
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Gastroenteritis
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Nervous system disorders
Cerebrospinal fistula
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Psychiatric disorders
Acute stress disorder
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Psychiatric disorders
Depression
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Renal and urinary disorders
Renal impairment
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
Other adverse events
| Measure |
MK0518 400 mg b.i.d.
n=174 participants at risk
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.
n=174 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.3%
4/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
1.7%
3/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
9/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
10.3%
18/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
6/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
4.6%
8/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
3.4%
6/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
General disorders
Asthenia
|
1.1%
2/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
2.3%
4/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
General disorders
Fatigue
|
4.0%
7/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
4.0%
7/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
General disorders
Influenza like illness
|
2.3%
4/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
1.7%
3/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Bronchitis
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
4.0%
7/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Gastroenteritis
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
1.1%
2/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Influenza
|
2.3%
4/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
3.4%
6/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Nasopharyngitis
|
6.9%
12/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
3.4%
6/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Pharyngitis
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
2.3%
4/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Sinusitis
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Syphilis
|
2.3%
4/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
1.7%
3/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
7/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
1.7%
3/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
6/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
1.7%
3/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
2.3%
4/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.1%
2/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Nervous system disorders
Dizziness
|
3.4%
6/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.00%
0/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Nervous system disorders
Headache
|
5.7%
10/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
5.2%
9/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Psychiatric disorders
Anxiety
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
1.1%
2/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Psychiatric disorders
Depression
|
4.6%
8/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Psychiatric disorders
Insomnia
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
3.4%
6/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
3/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
2.9%
5/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
|
Vascular disorders
Hypertension
|
2.3%
4/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
0.57%
1/174 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (31-Oct-2008) were collected.
The list of Other Adverse Events has an incidence cut off of 2%, includes clinical as well laboratory Adverse Events, and does not include Serious Adverse Events.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER