Trial Outcomes & Findings for MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED) (NCT NCT00443729)

NCT ID: NCT00443729

Last Updated: 2017-03-21

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

355 participants

Primary outcome timeframe

24 Weeks

Results posted on

2017-03-21

Participant Flow

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).

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

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	176	179
Overall Study Treated	176	178
Overall Study COMPLETED	166	172
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

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	0	1
Overall Study Lack of Efficacy	4	2
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	2	1
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK0518 400 mg b.i.d. n=176 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=178 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=354 Participants Total of all reporting groups
Age, Continuous	42.0 Years n=5 Participants	41.9 Years n=7 Participants	42.0 Years n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants	138 Participants n=7 Participants	275 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	68 Participants n=5 Participants	73 Participants n=7 Participants	141 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants	105 Participants n=7 Participants	213 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	33 Participants n=5 Participants	25 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	81 Participants n=7 Participants	166 Participants n=5 Participants
Race (NIH/OMB) More than one race	32 Participants n=5 Participants	42 Participants n=7 Participants	74 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	470.8 cells/mm3 n=5 Participants	482.4 cells/mm3 n=7 Participants	476.6 cells/mm3 n=5 Participants
Fasting (non-random) serum High-Density Lipoprotein-Cholesterol (HDL-C)	46.5 mg/dL STANDARD_DEVIATION 12.8 • n=5 Participants	47.9 mg/dL STANDARD_DEVIATION 12.7 • n=7 Participants	47.2 mg/dL STANDARD_DEVIATION 12.7 • n=5 Participants
Fasting (non-random) serum Low-Density Lipoprotein-Cholesterol (LDL-C)	103.5 mg/dL STANDARD_DEVIATION 41.0 • n=5 Participants	104.3 mg/dL STANDARD_DEVIATION 30.6 • n=7 Participants	103.9 mg/dL STANDARD_DEVIATION 36.2 • n=5 Participants
Fasting (non-random) serum cholesterol	214.7 mg/dL STANDARD_DEVIATION 69.7 • n=5 Participants	210.8 mg/dL STANDARD_DEVIATION 46.4 • n=7 Participants	212.7 mg/dL STANDARD_DEVIATION 59.2 • n=5 Participants
Fasting (non-random) serum triglyceride	204.5 mg/dL STANDARD_DEVIATION 156.3 • n=5 Participants	217.5 mg/dL STANDARD_DEVIATION 156.3 • n=7 Participants	212.5 mg/dL STANDARD_DEVIATION 156.3 • n=5 Participants
Non-HDL-C	168.2 mg/dL STANDARD_DEVIATION 71.8 • n=5 Participants	163.4 mg/dL STANDARD_DEVIATION 45.7 • n=7 Participants	165.8 mg/dL STANDARD_DEVIATION 60.3 • n=5 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=175 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=178 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	154 Participants	167 Participants

PRIMARY outcome

Timeframe: 24 Week last patient last visit

Population: All patients who took study medication were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=176 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=178 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	123 Participants	112 Participants
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks Without CAEs	53 Participants	66 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=166 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=165 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	-12.41 Percent Change Standard Deviation 15.80	1.29 Percent Change Standard Deviation 15.81

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=166 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=162 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	-14.77 Percent Change Standard Deviation 18.78	2.91 Percent Change Standard Deviation 20.26

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=161 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=162 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	3.99 Percent Change Standard Deviation 33.11	0.55 Percent Change Standard Deviation 21.51

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=166 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=162 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	-0.64 Percent Change Standard Deviation 20.14	-2.50 Percent Change Standard Deviation 16.50

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: 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

Outcome measures
Measure	MK0518 400 mg b.i.d. n=166 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=165 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	-42.82 Percent Change Standard Deviation 29.86	8.20 Percent Change Standard Deviation 52.73

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=168 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=165 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	-13.64 Percent Change Standard Deviation 16.25	3.55 Percent Change Standard Deviation 15.50

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=168 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=162 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	-15.83 Percent Change Standard Deviation 19.88	5.26 Percent Change Standard Deviation 19.90

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=163 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=162 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	5.12 Percent Change Standard Deviation 35.65	6.06 Percent Change Standard Deviation 26.22

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=168 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=162 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	-1.77 Percent Change Standard Deviation 20.56	-0.15 Percent Change Standard Deviation 16.62

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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

Outcome measures
Measure	MK0518 400 mg b.i.d. n=168 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=165 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	-44.50 Percent Change Standard Deviation 33.26	7.06 Percent Change Standard Deviation 55.42

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Week last patient last visit

Population: 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

Outcome measures
Measure	MK0518 400 mg b.i.d. n=176 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=178 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	4 Participants	8 Participants
Number of Patients With Serious CAEs Through 24 Weeks Without Serious CAEs	172 Participants	170 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Week last patient last visit

Population: 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

Outcome measures
Measure	MK0518 400 mg b.i.d. n=176 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=178 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	23 Participants	35 Participants
Number of Patients With Drug-related CAEs Through 24 Weeks Without drug-related CAEs	153 Participants	143 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Week last patient last visit

Population: All patients who took study medication were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=176 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=178 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 drugrelated CAEs	0 Participants	0 Participants
Number of Patients With Serious Drug-related CAEs Through 24 Weeks Without Serious drugrelated CAEs	176 Participants	178 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Week last patient last visit

Population: All patients who took study medication were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=176 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=178 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	176 Participants	178 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Week last patient last visit

Population: All patients who took study medication were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=176 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=178 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	0 Participants	0 Participants
Number of Patients That Discontinued Due to CAEs Through 24 Weeks Did Not Discontinue with CAEs	176 Participants	178 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Week last patient last visit

Population: All patients who took study medication were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=176 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=178 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	8 Participants	6 Participants
Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks Without LAEs	168 Participants	172 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Week last patient last visit

Population: All patients who took study medication were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=176 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=178 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 LAEs Through 24 Weeks With LAEs	4 Participants	1 Participants
Number of Patients With Drug-related LAEs Through 24 Weeks Without LAEs	172 Participants	177 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Week last patient last visit

Population: 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

Outcome measures
Measure	MK0518 400 mg b.i.d. n=176 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=178 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	176 Participants	178 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Week last patient last visit

Population: All patients who took study medication were included in the analysis

Outcome measures

Outcome measures
Measure	MK0518 400 mg b.i.d. n=176 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=178 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 Did Not Discontinue with LAEs	176 Participants	178 Participants
Number of Patients That Discontinued Due to LAEs Through 24 Weeks Discontinued with LAEs	0 Participants	0 Participants

Adverse Events

MK0518 400 mg b.i.d.

Serious events: 4 serious events

Other events: 94 other events

Deaths: 0 deaths

KALETRA™ 400/100 mg b.i.d.

Serious events: 8 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

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

Measure	MK0518 400 mg b.i.d. n=176 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=178 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 Coronary artery occlusion	0.00% 0/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Diarrhoea	0.57% 1/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.00% 0/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Gastritis	0.57% 1/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.00% 0/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Nausea	0.00% 0/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Peptic ulcer	0.00% 0/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Vomiting	0.00% 0/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
General disorders Pyrexia	0.00% 0/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	1.1% 2/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Infections and infestations Appendicitis	0.57% 1/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.00% 0/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Infections and infestations Urinary tract infection	0.00% 0/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Metabolism and nutrition disorders Dehydration	0.00% 0/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.57% 1/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.00% 0/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma AIDS related	0.57% 1/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.57% 1/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.00% 0/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.

Measure	MK0518 400 mg b.i.d. n=176 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=178 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 Abdominal distension	2.3% 4/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	3.4% 6/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Abdominal pain	2.3% 4/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	1.7% 3/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Abdominal pain upper	2.3% 4/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	1.1% 2/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Constipation	2.3% 4/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Diarrhoea	4.0% 7/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	16.3% 29/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Dry mouth	2.3% 4/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.00% 0/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Flatulence	1.1% 2/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	3.4% 6/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Gastritis	3.4% 6/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	1.1% 2/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Nausea	3.4% 6/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	5.1% 9/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Gastrointestinal disorders Vomiting	0.57% 1/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	2.2% 4/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
General disorders Fatigue	2.8% 5/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	3.4% 6/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
General disorders Pyrexia	2.8% 5/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	2.8% 5/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Infections and infestations Gastroenteritis	1.1% 2/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	3.4% 6/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Infections and infestations Genital herpes	2.3% 4/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	1.1% 2/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Infections and infestations Influenza	4.0% 7/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	3.4% 6/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Infections and infestations Nasopharyngitis	2.8% 5/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	3.4% 6/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Infections and infestations Pharyngitis	2.8% 5/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	1.1% 2/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Infections and infestations Respiratory tract infection	2.3% 4/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	2.2% 4/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Infections and infestations Sinusitis	2.3% 4/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	2.2% 4/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Infections and infestations Upper respiratory tract infection	9.1% 16/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	8.4% 15/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Investigations Alanine aminotransferase increased	2.8% 5/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	1.7% 3/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.57% 1/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	3.4% 6/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Musculoskeletal and connective tissue disorders Back pain	3.4% 6/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	0.56% 1/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Nervous system disorders Dizziness	1.7% 3/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	3.9% 7/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Nervous system disorders Headache	7.4% 13/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	3.9% 7/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Nervous system disorders Paraesthesia	1.7% 3/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	2.2% 4/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Psychiatric disorders Depression	4.0% 7/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	2.8% 5/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Psychiatric disorders Insomnia	3.4% 6/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	3.9% 7/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Respiratory, thoracic and mediastinal disorders Cough	2.3% 4/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	1.7% 3/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.3% 4/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	1.1% 2/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Skin and subcutaneous tissue disorders Rash	2.8% 5/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	2.8% 5/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.
Vascular disorders Hypertension	2.8% 5/176 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.	1.1% 2/178 • Adverse experiences that occurred after randomization and through Week 24 last patient last visit (17-Oct-2008) were collected.