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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition:	HIV Infection
Interventions:	Drug: MK0518 (raltegravir); Drug: Comparator: KALETRA™ (lopinavir (+) ritonavir ); Drug: Comparator: placebo

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase III; First Patient In: 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

  Baseline Characteristics

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Population Description

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

Reporting Groups

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

Baseline Measures

	MK0518 400 mg b.i.d.	KALETRA™ 400/100 mg b.i.d.	Total
Overall Participants Analyzed; [Units: Participants]	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)

  Outcome Measures

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1. Primary:

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

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2. Primary:

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

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3. Primary:

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

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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 ]

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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 ]

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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 ]

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7. Primary:

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

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Measure Type	Primary
Measure Title	Median Percent Change From Baseline in Serum Triglyceride at Week 12
Measure Description	Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time Frame	Baseline and Week 12

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who had both baseline and at least one post-baseline measurement were included in the analysis

Reporting Groups

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

Measured Values

	MK0518 400 mg b.i.d.	KALETRA™ 400/100 mg b.i.d.
Participants Analyzed	142	146
Median Percent Change From Baseline in Serum Triglyceride at Week 12; [Units: Percent Change]; Median (Standard Deviation)	-41.50 (35.37)	3.56 (59.36)

No statistical analysis provided for Median Percent Change From Baseline in Serum Triglyceride at Week 12

8. Secondary:

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

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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 ]

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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 ]

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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 ]

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12. Secondary:

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

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13. Other Pre-specified:

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

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14. Other Pre-specified:

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

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15. Other Pre-specified:

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

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16. Other Pre-specified:

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

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17. Other Pre-specified:

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

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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 ]

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19. Other Pre-specified:

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

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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 ]

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21. Other Pre-specified:

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

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22. Other Pre-specified:

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

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23. Other Pre-specified:

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

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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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™.

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