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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase III; First Patient In: 20-Jun-2007; Last Patient Last Visit for Week 24 (primary endpoint): 31-Oct-2008 47 Sites (US, Canada, Denmark, Germany, Italy, Portugal, Spain, United Kingdom, and Australia).

Pre-Assignment Details

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

Reporting Groups

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

Participant Flow:   Overall Study

	MK0518 400 mg b.i.d.	KALETRA™ 400/100 mg b.i.d.
STARTED	177	175
Treated	174	174
COMPLETED	149	157
NOT COMPLETED	28	18
Never Treated	3	1
Adverse Event	7	3
Lack of Efficacy	3	1
Lost to Follow-up	0	4
Physician Decision	4	2
Protocol Violation	1	1
Withdrawal by Subject	9	6
Progressive Disease	1	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

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

Baseline Measures

	MK0518 400 mg b.i.d.	KALETRA™ 400/100 mg b.i.d.	Total
Overall Participants Analyzed  [Units: Participants]	174	174	348
Age  [Units: Years] Mean (Full Range)	44.4   (23 to 70)	43.6   (24 to 71)	44.0   (23 to 71)
Sex: Female, Male  [Units: Participants] Count of Participants
Female	28  16.1%	45  25.9%	73  21.0%
Male	146  83.9%	129  74.1%	275  79.0%
Ethnicity (NIH/OMB)  [Units: Participants] Count of Participants
Hispanic or Latino	25  14.4%	23  13.2%	48  13.8%
Not Hispanic or Latino	149  85.6%	151  86.8%	300  86.2%
Unknown or Not Reported	0   0.0%	0   0.0%	0   0.0%
Race (NIH/OMB)  [Units: Participants] Count of Participants
American Indian or Alaska Native	0   0.0%	0   0.0%	0   0.0%
Asian	2   1.1%	3   1.7%	5   1.4%
Native Hawaiian or Other Pacific Islander	0   0.0%	0   0.0%	0   0.0%
Black or African American	24  13.8%	28  16.1%	52  14.9%
White	146  83.9%	141  81.0%	287  82.5%
More than one race	2   1.1%	2   1.1%	4   1.1%
Unknown or Not Reported	0   0.0%	0   0.0%	0   0.0%
Cluster of Differentiation 4 (CD4) Cell Count  [Units: Cells/mm3] Mean (Full Range)	477.6   (65 to 1446)	508.2   (87 to 1510)	492.9   (65 to 1510)
Fasting (non-random) serum High Density Lipoprotein-Cholesterol (HDL-C)  [Units: mg/dL] Mean (Standard Deviation)	48.8  (16.4)	47.1  (14.0)	47.9  (15.2)
Fasting (non-random) serum Low Density Lipoprotein-Cholesterol (LDL-C)  [Units: mg/dL] Mean (Standard Deviation)	115.3  (40.3)	104.8  (35.9)	110.0  (38.5)
Fasting (non-random) serum cholesterol  [Units: mg/dL] Mean (Standard Deviation)	215.3  (48.2)	203.9  (52.3)	209.6  (50.6)
Fasting (non-random) serum triglyceride [1]  [Units: mg/dL] Mean (Standard Deviation)	189.5  (134.0)	162.0  (112.6)	175.0  (126.5)
[1] Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Non-HDL-C  [Units: mg/dL] Mean (Standard Deviation)	165.5  (48.5)	156.8  (53.0)	161.1  (50.9)

1.  Primary:

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

2.  Primary:

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

3.  Primary:

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

4.  Primary:

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

5.  Primary:

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

6.  Primary:

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

7.  Primary:

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

8.  Secondary:

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

9.  Secondary:

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

10.  Secondary:

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

11.  Secondary:

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

12.  Secondary:

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

13.  Other Pre-specified:

Number of Patients With Serious CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

14.  Other Pre-specified:

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

15.  Other Pre-specified:

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

16.  Other Pre-specified:

Number of Patients That Died by 24 Week Last Patient Last Visit   [ Time Frame: 24 Week last patient last visit ]

17.  Other Pre-specified:

Number of Patients That Discontinued Due to CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

18.  Other Pre-specified:

Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

19.  Other Pre-specified:

Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

20.  Other Pre-specified:

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

21.  Other Pre-specified:

Number of Patients With Serious LAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

22.  Other Pre-specified:

Number of Patients That Discontinued Due to LAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

23.  Other Pre-specified:

Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks   [ Time Frame: 24 Week last patient last visit ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The reason for early termination: Study was terminated after the primary efficacy analysis at Week 24 did not demonstrate non-inferiority of MK0518 versus KALETRA™.