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: 11-Jun-2007; Last Patient Last Visit for Week 24 (primary endpoint): 17-Oct- 2008 34 Sites (US, Peru, Brazil, Colombia, Mexico, South Africa, Thailand, India, and Australia).

Pre-Assignment Details

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.	No text entered.
KALETRA™ 400/100 mg b.i.d.	No text entered.

Participant Flow:   Overall Study

	MK0518 400 mg b.i.d.	KALETRA™ 400/100 mg b.i.d.
STARTED	176	179
Treated	176	178
COMPLETED	166	172
NOT COMPLETED	10	7
Never Treated	0	1
Lack of Efficacy	4	2
Lost to Follow-up	0	1
Physician Decision	2	1
Protocol Violation	1	1
Withdrawal by Subject	3	1

Reporting Groups

	Description
MK0518 400 mg b.i.d.	No text entered.
KALETRA™ 400/100 mg b.i.d.	No text entered.

Baseline Measures

	MK0518 400 mg b.i.d.	KALETRA™ 400/100 mg b.i.d.	Total
Number of Participants   [units: participants]	176	178	354
Age   [units: Years] Mean ( Full Range )	42.0 ( 21 to 71 )	41.9 ( 23 to 74 )	42.0 ( 21 to 74 )
Gender   [units: participants]
Female	39	40	79
Male	137	138	275
Ethnicity (NIH/OMB)   [units: participants]
Hispanic or Latino	68	73	141
Not Hispanic or Latino	108	105	213
Unknown or Not Reported	0	0	0
Race (NIH/OMB)   [units: participants]
American Indian or Alaska Native	0	1	1
Asian	26	28	54
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	33	25	58
White	85	81	166
More than one race	32	42	74
Unknown or Not Reported	0	0	0
Cluster of Differentiation 4 (CD4) Cell Count   [units: cells/mm3] Mean ( Full Range )	470.8 ( 16 to 1916 )	482.4 ( 100 to 1744 )	476.6 ( 16 to 1916 )
Fasting (non-random) serum High-Density Lipoprotein-Cholesterol (HDL-C)   [units: mg/dL] Mean ± Standard Deviation	46.5 ± 12.8	47.9 ± 12.7	47.2 ± 12.7
Fasting (non-random) serum Low-Density Lipoprotein-Cholesterol (LDL-C)   [units: mg/dL] Mean ± Standard Deviation	103.5 ± 41.0	104.3 ± 30.6	103.9 ± 36.2
Fasting (non-random) serum cholesterol   [units: mg/dL] Mean ± Standard Deviation	214.7 ± 69.7	210.8 ± 46.4	212.7 ± 59.2
Fasting (non-random) serum triglyceride[1] [units: mg/dL] Mean ± Standard Deviation	204.5 ± 156.3	217.5 ± 156.3	212.5 ± 156.3
Non-HDL-C   [units: mg/dL] Mean ± Standard Deviation	168.2 ± 71.8	163.4 ± 45.7	165.8 ± 60.3

1.  Primary:

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

2.  Primary:

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

3.  Primary:

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

4.  Primary:

Mean Percent Change From Baseline in Non-HDL-C at Week 12   [ Baseline and Week 12 ]

5.  Primary:

Mean Percent Change From Baseline in Fasting Serum LDL-C at Week 12   [ Baseline and Week 12 ]

6.  Primary:

Mean Percent Change From Baseline in Fasting Serum HDL-C at Week 12   [ Baseline and Week 12 ]

7.  Primary:

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

8.  Secondary:

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

9.  Secondary:

Mean Percent Change From Baseline in Non-HDL-C at Week 24   [ Baseline and Week 24 ]

10.  Secondary:

Mean Percent Change From Baseline in Fasting Serum LDL-C at Week 24   [ Baseline and Week 24 ]

11.  Secondary:

Mean Percent Change From Baseline in Fasting Serum HDL-C at Week 24   [ Baseline and Week 24 ]

12.  Secondary:

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

13.  Other Pre-specified:

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

14.  Other Pre-specified:

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

15.  Other Pre-specified:

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

16.  Other Pre-specified:

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

17.  Other Pre-specified:

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

18.  Other Pre-specified:

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

19.  Other Pre-specified:

Number of Patients With Drug-related LAEs Through 24 Weeks   [ 24 Week last patient last visit ]

20.  Other Pre-specified:

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

21.  Other Pre-specified:

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