| Primary | Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24 | | 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. | Posted | | Number | | Participants | | 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks | | All patients who took study medication were included in the analysis | Posted | | Number | | Participants | | 24 Week last patient last visit | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Number of Patients With Serious CAEs Through 24 Weeks | 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 | All patients who took study medication were included in the analysis | Posted | | Number | | Participants | | 24 Week last patient last visit | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Number of Patients With Drug-related CAEs Through 24 Weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician, according to his/her best clinical judgement) CAEs. | All patients who took study medication were included in the analysis | Posted | | Number | | Participants | | 24 Week last patient last visit | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Number of Patients With Serious Drug-related CAEs Through 24 Weeks | 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 | All patients who took study medication were included in the analysis | Posted | | Number | | Participants | | 24 Week last patient last visit | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Number of Patients That Died by 24 Week Last Patient Last Visit | | All patients who took study medication were included in the analysis | Posted | | Number | | Participants | | 24 Week last patient last visit | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Number of Patients That Discontinued Due to CAEs Through 24 Weeks | | All patients who took study medication were included in the analysis | Posted | | Number | | Participants | | 24 Week last patient last visit | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks | | All patients who took study medication were included in the analysis | Posted | | Number | | Participants | | 24 Week last patient last visit | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Number of Patients With Drug-related LAEs Through 24 Weeks | | All patients who took study medication were included in the analysis | Posted | | Number | | Participants | | 24 Week last patient last visit | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Number of Patients With Serious LAEs Through 24 Weeks | 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 | All patients who took study medication were included in the analysis | Posted | | Number | | Participants | | 24 Week last patient last visit | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Other Pre-specified | Number of Patients That Discontinued Due to LAEs Through 24 Weeks | | All patients who took study medication were included in the analysis | Posted | | Number | | Participants | | 24 Week last patient last visit | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Primary | Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12 | | Patients who had both baseline and at least one post-baseline measurement were included in the analysis | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Primary | Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 | | Patients who had both baseline and at least one post-baseline measurement were included in the analysis | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Primary | Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 | | Patients who had both baseline and at least one post-baseline measurement were included in the analysis | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Primary | Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12 | | Patients who had both baseline and at least one post-baseline measurement were included in the analysis | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Primary | Median Percent Change From Baseline in Serum Triglyceride at Week 12 | Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile. | Patients who had both baseline and at least one post-baseline measurement were included in the analysis | Posted | | Median | Standard Deviation | Percent Change | | Baseline and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24 | | Patients who had both baseline and at least one post-baseline measurement were included in the analysis | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 | | Patients who had both baseline and at least one post-baseline measurement were included in the analysis | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24 | | Patients who had both baseline and at least one post-baseline measurement were included in the analysis | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24 | | Patients who had both baseline and at least one post-baseline measurement were included in the analysis | Posted | | Mean | Standard Deviation | Percent Change | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |
| Secondary | Median Percent Change From Baseline in Serum Triglyceride at Week 24 | Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile. | Patients who had both baseline and at least one post-baseline measurement were included in the analysis | Posted | | Median | Standard Deviation | Percent Change | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| |