| Primary | Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%) | Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | Percentage of brachial artery diameter | | Baseline (Day 1 of Week 1) to Week 24 | | | | ID | Title | Description |
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| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-4.8(-7.0 to 0.3)
- OG001-0.6(-4.7 to 3.3)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Nonparametric Wilcoxon rank sum test | | 0.08 | | | | | | 2-Sided | | | | | | | No | Superiority or Other | | |
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| Secondary | Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%) | Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | Percentage of brachial artery diameter | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL | | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Number | | Participants | | Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52) | | | | ID | Title | Description |
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| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline to Week 48 in Circulating Endothelial Cells | | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Full Range | Endothelial cells | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells | | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Full Range | Endothelial cells | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL | | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline (Day1 of Week 1), Week 24, and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline in Mean High-density Lipoprotein (HDL) Cholesterol at Week 24 and Week 48: Median Change in HDL | | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Week 24, and Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline in Mean Triglycerides at Week 24 and Week 48: Median Change in Triglycerides | | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | mg/dL | | Baseline, Week 24, and Week 48 | | | | ID | Title | Description |
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| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline in Insulin Sensitivity at Week 24 and Week 48: Median Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | The Homeostatic Model Assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function. HOMA-IR is reflected in the diminished effect of insulin on hepatic glucose production. HOMA-IR is calculated as: (Glucose [mg/dL] X Insulin [pmol/L]) / (405 X 6.945). Higher scores indicate worse insulin resistance. | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | HOMA score | | Baseline, Week 24, and Week 48 | | | | ID | Title | Description |
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| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline in Mean Framingham Risk Score at Week 24 and Week 48: Medican Change in Framingham Risk Score | The Framingham Risk Score is used to estimate the 10-year cardiovascular risk of a participant. It is calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, and systolic blood pressure. The framingham risk score is calculated as: for males: 0 point (1 percentage) up to 17 points (30 percentages); whereas for females: 0 to 9 points (1 percentage) up to 25 points (30 percentage). Higher scores indicate high cardiovascular risk. | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | Framingham risk score | | Baseline, Week 24, and Week 48 | | | | ID | Title | Description |
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| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline to Week 48 in Leg Fat Content: Median Change in Leg Fat (Total) | Leg fat content will be analyzed by Dual Energy X-ray Absortiometry (DEXA scan). | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | Percentage of fat | | Baseline to Week 48 | | | | ID | Title | Description |
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| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline to Week 48 in Visceral Fat Content in Abdomen: Median Change in Visceral Abdominal Tissue (VAT) | Visceral fat content in abdomen will be analyzed with median change in VAT by an abdomen Computerized Tomography. | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | cm square | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline to Week 48 in Femoral Neck T Score: Median Change in Femoral Neck T Score | T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density. | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | T score | | Baseline to Week 48 | | | | ID | Title | Description |
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| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline to Week 48 in Femoral Neck Z Score: Median Change in Femoral Neck Z Score | Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of '0' and a standard deviation of '1'. Z score lower than its mean indicate low bone mineral density. | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | Z score | | Baseline to Week 48 | | | | ID | Title | Description |
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| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline to Week 48 in Lumbar T Score: Median Change in Lumbar T Score | T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density. | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | T score | | Baseline to Week 48 | | | | ID | Title | Description |
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| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline to Week 48 in Lumbar Z Score: Median Change in Lumbar Z Score | Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of '0' and a standard deviation of '1'. Z score lower than its mean indicate low bone mineral density. | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | Z score | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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| Secondary | Change From Baseline in Cluster of Differentiation 4 (CD4) Count Over Week 48 | | Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment. | Posted | | Median | Inter-Quartile Range | CD4 cells | | Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | Monotherapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily | | OG001 | Combination Therapy | 2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) |
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