| Primary | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) | The primary endpoint is the percent change in bone mineral density (BMD) at total hip (as measured by DXA scan) from baseline (week 0) to week 48. | The primary analysis was as-treated which included only participants with total hip BMD measurements available at both week 0 and week 48 who remained on their randomized MVC or TDF component by the time week 48 measurement was taken without an interruption of treatment of more than 10 weeks. | Posted | | Median | Inter-Quartile Range | percentage change | | Week 0, week 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.51(-2.93 to -0.11)
- OG001-2.40(-4.30 to -1.32)
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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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| The null hypothesis is that there is no difference between the two arms in the percent of total hip BMD change from baseline to week 48 | Wilcoxon (Mann-Whitney) | Stratified Wilcoxon rank sum test stratified by age (<30 and >=30 years) | <0.001 | Two-sided p-value without adjustment for multiple testing, interpreted at the 5% nominal level of significance | | | | | 2-Sided | | | | | | | | Superiority or Other (legacy) | | |
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| Secondary | Percent Change in Lumbar Spine Bone Mineral Density (BMD) | The percent change in bone mineral density (BMD) at lumbar spine (as measured by DXA scan) from baseline (week 0) to week 48. | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | percentage change | | Week 0, week 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Change in CD4 Count From Baseline to Week 24 | Change in CD4 count from baseline (week 0) to week 24 | Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis. | Posted | | Median | Inter-Quartile Range | cells/mm^3 | | Week 0, week 24 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Change in CD4 Count From Baseline to Week 48 | Change in CD4 count from baseline (week 0) to week 48 | Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis. | Posted | | Median | Inter-Quartile Range | cells/mm^3 | | Week 0, week 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | CD8+ T-cell Change From Baseline to Week 48 | CD8+ T-cell change from baseline to week 48 | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | cell/mm^3 | | At weeks 0 and 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48 | percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | percentage change | | At weeks 0 and 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48 | percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100% | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | percentage change | | At weeks 0 and 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm: DRV/r + MVC + FTC + TDF Placebo | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. Maraviroc: Maraviroc was administered orally once a day as one 150 mg tablet. | | OG001 | TDF Arm: DRV/r + TDF + FTC + MVC Placebo | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one tablet. |
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| Secondary | Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48 | percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | percentage change | | At weeks 0 and 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48 | percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | percentage change | | At weeks 0 and 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48 | percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | percentage change | | At weeks 0 and 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48 | percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100% | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | percentage change | | At weeks 0 and 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Change in Levels of IL-6 From Baseline to Week 48 | Change in levels of Interleukin 6 (IL-6) from baseline to week 48 | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | pg/ml | | At weeks 0 and 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Change in Level of IP-10 From Baseline to Week 48 | Change in level of Interferon gamma-induced protein 10 (IP-10) from baseline to week 48 | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | pg/ml | | At weeks 0 and 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Change in Levels of sCD163 From Baseline to Week 48 | Change in levels of soluble CD163 from baseline to week 48 | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | ng/ml | | At weeks 0 and 48 | | | | ID | Title | Description |
|---|
| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Change in Levels of sCD14 From Baseline | Change in levels of soluble CD14 from baseline | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | ng/ml | | At weeks 0 and 48 | | | | ID | Title | Description |
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| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Change in Levels of D-dimer From Baseline | Change in levels of D-dimer from baseline | As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks. | Posted | | Median | Inter-Quartile Range | ng/ml | | At weeks 0 and 48 | | | | ID | Title | Description |
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| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Cumulative Probability of Virologic Failure by Week 48 | Confirmed virologic failure is defined as confirmed plasma HIV-1 RNA levels > 1000 copies/mL at or after week 16 and before week 24, or confirmed HIV-1 RNA levels> 200 copies/mL at or after week 24. Participants who discontinued the study with an unconfirmed virologic failure (HIV-1 RNA > 1000 copies at 16 weeks or HIV-1 RNA level > 200 copies/mL at or after week 24) are considered as virologic failures at the study visit week of the unconfirmed value. Time to virologic failure is defined as the time from study entry to the planned visit week of the initial failure. Product-limit estimates for the survival function were used to estimate the cumulative probability of virologic failure over time and its corresponding 95% confidence interval for each treatment group. | All participants who started study treatment | Posted | | Number | 95% Confidence Interval | cumulative probability per 100 persons | | From study treatment initiation to week 48 | | | | ID | Title | Description |
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| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. |
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| Secondary | Number of Participants Who Experienced Bone Fractures | Number of participants who experienced bone fractures during the study | All participants who started study treatment | Posted | | Number | | participants | | From study treatment initiation to week 48 | | | | ID | Title | Description |
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| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Number of Participants Who Died During the Study | Number of participants who died during the study | All participants who started study treatment | Posted | | Number | | participants | | From study treatment initiation to week 48 | | | | ID | Title | Description |
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| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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| Secondary | Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events | Grade 3 or 4 primary adverse events includes primary signs/symptoms, primary laboratory abnormalities, or primary diagnoses. See DAIDS AE Grading Table Version 1.0, Dec 2004 (Clarification, Aug 2009) | All participants who initiated study treatment | Posted | | Number | | participants | | From study treatment initiation to week 48 | | | | ID | Title | Description |
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| OG000 | MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet. | | OG001 | TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet. Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food. Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day. Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule. Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet. |
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