| Primary | Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies Per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach | Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 48), 3) no viral load data in the Week 48 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. | The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here N (number of participants analyzed) refers to 362 for test group and 363 for control group. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00091.4± 88.1(88.1 to 94.1)
- OG00188.4± 84.7(84.7 to 91.5)
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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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| | Mantel Haenszel | | < 0.001 | inferiority margin is 10%. | Difference in percentage | 2.7 | | | 2-Sided | 95 | -1.6 | 7.1 | | | | | Non-Inferiority | One-sided p-value for non-inferiority of Test versus Control arm. The non- | |
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| Secondary | Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach | Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. | The analysis population is ITT. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure and n (number analyzed) signifies participants analyzed for this OM for specific categories at specified timepoints. Participants received treatment from baseline till Week 48/Switch in control arm and from switch till Week 96 in Switch to D/C/F/TAF arm. Therefore, Week 96 and Week 48 data was not collected for both arms at respective timepoints. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Weeks 48 and 96 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm | Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. | The analysis population is ITT. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure and n (number analyzed) signifies participants analyzed for this OM for specific categories at specified timepoints. Participants received treatment from baseline till Week 48/Switch in control arm and from switch till Week 96 in Switch to D/C/F/TAF arm. Therefore, Week 96 and Week 48 data was not collected for both arms at respective timepoints. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Week 48 and 96 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Change From Baseline in log10 HIV-1 RNA Levels at Week 48 | Change from baseline in log10 HIV-1 RNA levels were reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Based on not completed (NC) equal to (=) failure (F) analysis with values after discontinuation imputed with the baseline value. Other (intermittent) missing values are imputed using last observation carried forward (LOCF). | Posted | | Least Squares Mean | Standard Error | log10 HIV-1 RNA copies per mL | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | |
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| Secondary | Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48 | The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Week 48 were assessed. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Based on NC = F analysis with values after discontinuation imputed with the baseline value. Other (intermittent) missing values are imputed using LOCF. | Posted | | Least Squares Mean | Standard Error | Cells per millimeter cube (cells/mm^3) | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) |
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| Secondary | Change From Baseline in Serum Creatinine at Week 48 | Change from baseline in serum creatinine at Week 48 was reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | | Least Squares Mean | Standard Error | milligram per deciliter (mg/dL) | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
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| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula at Week 48 | Change from baseline in eGFRcr was calculated using the CKD-EPI equation as per which Stage 1 (normal or high GFR [>=90 mL/min]); Stage 2 (Mild CKD [60 to 90 mL/min]); Stage 3 (Moderate CKD [30 to 59mL/min]); Stage 4 (Severe CKD [15 to 29 mL/min]); Stage 5 (End Stage CKD [<15 mL/min]). The eGFRcr was assessed by calculating serum creatinine (Scr) using the equation: eGFRcr milliliter per minute per 1.72 meter square (mL/min/1.73m^2) = 144*(Scr/0.7)^-0.329*0.993^age (Scr =< 0.7 mg/dL) and eGFRcr mL/min/1.73m^2 = 144*(Scr/0.7)^-1.209*0.993^age (Scr >0.7 mg/dL) for female participants and eGFRcr mL/min/1.73m^2 = 141*(Scr/0.9)^-0.411*0.993^age (Scr =<0.9 mg/dL) and eGFRcr mL/min/1.73m^2 = 141*(Scr/0.9)^-1.209*0.993^age (Scr >0.9 mg/dL) for male participants. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | | Least Squares Mean | Standard Error | mL/min/1.73 m^2 | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine by (Cockcroft-Gault Formula) at Week 48 | Change from baseline in eGFRcr by cockcroft-gault formula at Week 48. The eGFRcr was assessed by calculated creatinine clearance (CrCl) using the Cockcroft-Gault formula, and was assessed using CrCl [mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit (kilogram [kg]), C is the serum concentration of creatinine [mg/dL], R = 1 if the participant is male and = 0.85 if female. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | | Least Squares Mean | Standard Error | milliliter per minute (mL/min) | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula at Week 48 | Change from baseline in eGFRcyst was calculated using the CKD-EPI equation as per which Stage 1 (normal or high GFR) >= 90 indicates normal kidney function; Stage 2 (Mild CKD): 60 to 89 mL/min indicates mildly reduced kidney function; Stage 3 (Moderate CKD): 30 to 59 mL/min indicates moderately reduced kidney function; Stage 4 (Severe CKD): 15 to 29 mL/min indicates severely reduced kidney function; Stage 5 (End Stage of CKD): <15 mL/min indicate very severe or end stage kidney failure. The eGFRcyst was assessed by calculated serum cystatin C (Scyst) using the equation: eGFRcyst mL/min/1.73m^2 = 133 * (Scyst/0,8)^-0.499 * 0.996^age [* 0.932 if female] (Scyst =<0.8 mg/L) and eGFRcr mL/min/1.73m^2 = 133 * (Scyst/0,8)^-1.328 * 0.996^age [* 0.932 if male] (Scyst >0.8 mg/L). | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | | Least Squares Mean | Standard Error | mL/min/1.73 m^2 | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 48 | AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | | Number | | percentage of participants | | Up to Weeks 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 | Change from baseline in UPCR at Week 48 was reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | | Median | Full Range | milligram per gram (mg/g) | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
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| Secondary | Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48 | Change from baseline in UACR at Week 48 was reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | | Median | Full Range | mg/g | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
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| Secondary | Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48 | Change from baseline in URBPCR at Week 48 were reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participant analyzed) signifies participants evaluated for this outcome measure. | Posted | | Median | Full Range | microgram per gram (mcg/g) | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
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| Secondary | Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48 | Change from baseline in UB2MGCR at Week 48 were reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participant analyzed) signifies participants evaluated for this outcome measure. | Posted | | Median | Full Range | mcg/g | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
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| Secondary | Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48 | Percent change from baseline in FEPO4 at Week 48 was reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | | Median | Full Range | Percent change | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir | AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post-dose. | Pharmacokinetic (PK) analysis set included all participants who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of DRV was analyzed only for test arm as per planned analyses. Here, 'N' (number of participants analyzed) number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | hours*nanogram per milliliter (h*ng/mL) | | 0 to 24 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Darunavir 800 mg [D/C/F/TAF] | Participants received DRV 800 mg along with COBI 150 mg, FTC 200 mg, TAF 10 mg as a (D/C/F/TAF) FDC oral tablet once daily along with DRV/COBI FDC-matching placebo and FTC/TDF FDC-matching placebo tablets once daily up to Week 48. |
| |
| Secondary | Predose (Trough) Plasma Concentration (C0h) of Darunavir | C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration. | PK analysis set included all participants who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of DRV was analyzed only for test arm as per planned analyses. Here, 'N' (number of participants analyzed) number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | 30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Darunavir 800 mg [D/C/F/TAF (Test)] | Participants received DRV 800 mg along with COBI 150 mg, FTC 200 mg, TAF 10 mg as a (D/C/F/TAF) FDC oral tablet once daily along with DRV/COBI FDC-matching placebo and FTC/TDF FDC-matching placebo tablets once daily up to Week 48. |
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| Secondary | Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide | The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. | PK analysis set included all participants who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of TAF was analyzed only for test arm as per planned analyses. Here, 'N' (number of participants analyzed) number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h*ng/mL | | 30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose) | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)] | Participants received TAF 10 mg along with DRV 800 mg, COBI 150 mg, FTC 200 mg as a (D/C/F/TAF) FDC oral tablet once daily along with DRV/COBI FDC-matching placebo and FTC/TDF FDC-matching placebo tablets once daily up to Week 48. |
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| Secondary | Plasma Concentrations 2 Hours After Dosing (C0-2h) of Tenofovir Alafenamide | C0-2h is defined as the plasma concentrations 2 hours after dosing. | PK analysis set included all participants who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of TAF was analyzed only for test arm as per planned analyses. Here, 'N' (number of participants analyzed) number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | 0 to 2 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)] | Participants received TAF 10 mg along with DRV 800 mg, COBI 150 mg, FTC 200 mg as a (D/C/F/TAF) FDC oral tablet once daily along with DRV/COBI FDC-matching placebo and FTC/TDF FDC-matching placebo tablets once daily up to Week 48. |
| |
| Secondary | Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD) | The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by dual energy x-ray absorptiometry (DEXA) scan. Positive values are "best values" and negative values are "worst values" of change. Percent change from baseline in hip and spine BMD was assessed. | Bone investigation substudy (BIS) analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. | Posted | | Least Squares Mean | Standard Error | Percent change | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | |
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| Secondary | Change From Baseline in BMD T-score of Hip and Spine | BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. | BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, 'n' (number analyzed) signifies participants analyzed for this outcome measure at specified timepoints. | Posted | | Mean | Standard Error | BMD T-score | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) |
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| Secondary | Change From Baseline in Alkaline Phosphatase (ALP) Levels at Weeks 24 and 48 | Change from baseline in ALP at Weeks 24 and 48 was reported. | BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, 'n' (number analyzed) signifies participants analyzed for this outcome measure at specified timepoints. | Posted | | Mean | Standard Error | Units per liter (U/L) | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
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| Secondary | Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Weeks 24 and 48 | Change from baseline in serum P1NP at Weeks 24 and 48 were reported. | BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, 'n' (number analyzed) signifies participants analyzed for this outcome measure at specified timepoints. | Posted | | Mean | Standard Error | microgram per liter (mcg/L) | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | |
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| Secondary | Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Weeks 24 and 48 | Change from baseline in serum CTX at Weeks 24 and 48 were reported. | BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, 'n' (number analyzed) signifies participants analyzed for this outcome measure at specified timepoints. | Posted | | Mean | Standard Error | mcg/L | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
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| Secondary | Change From Baseline in Levels of Parathyroid Hormone (PTH) at Weeks 24 and 48 | Change from baseline in PTH at Weeks 24 and 48 were reported. | BIS analysis set included participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, 'n' (number analyzed) signifies participants analyzed for this outcome measure at specified timepoints. | Posted | | Mean | Standard Error | Picomol per liter (pmol/L) | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
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| Secondary | Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48 | Change from baseline in 25-OH Vitamin D levels at Week 24 and 48 were reported. | BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, 'n' (number analyzed) signifies participants analyzed for this outcome measure at specified timepoints. | Posted | | Mean | Standard Error | nanomol per liter (nmol/L) | | Baseline, Weeks 24 and 48 | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | |
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| Secondary | Percentage of Participants With HIV-1 RNA <50 Copies Per mL at Week 96 Defined by FDA Snapshot Approach | Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 96), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 96), 3) no viral load data in the Week 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At Week 96 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Change From Reference in log10 HIV-1 RNA Levels at Week 96 | Change from reference in log10 HIV-1 RNA levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for Test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Based on not completed (NC) equal to (=) failure (F) analysis with values after discontinuation imputed with the baseline value. Other (intermittent) missing values are imputed using last observation carried forward (LOCF). Here N (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | | Least Squares Mean | Standard Error | log10 HIV-1 RNA copies per mL | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Change From Reference in CD4+ Cell Count at Week 96 | The immunologic change was determined by changes in cluster of differentiation (CD4+) cell count. Change from reference in CD4+ cell count at Week 96 was assessed. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Based on NC=F analysis with values after discontinuation imputed with the baseline value. Other (intermittent) missing values are imputed using LOCF. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. | Posted | | Least Squares Mean | Standard Error | cells/mm^3 | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability | Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure and n (number analyzed) signifies participants analyzed for this outcome measure at specified timepoints. | Posted | | Number | | percentage of participants | | Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years) | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 96 | AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. This outcome measure was planned to be reported for participants who received D/C/F/TAF in group 1 and who switched to D/C/F/TAF in group 2. | Posted | | Number | | percentage of participants | | Up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Change From Reference in Serum Creatinine | Change from reference in serum creatinine was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Median | Full Range | mg/dL | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Change From Reference in eGFRcr by CKD-EPI Formula | Change from reference in eGFRcr was calculated using the CKD-EPI equation as per Stage 1 (normal or high GFR) to Stage 5 (End Stage of CKD). The eGFRcr was assessed by calculating serum creatinine (Scr) using the CKD-EPI equation: eGFRcr milliliter per minute per 1.72 meter square (mL/min/1.73m^2) = 144 * (Scr/0.7)^-0.329 * 0.993^age (Scr =< 0.7 mg/dL) and eGFRcr mL/min/1.73m^2 = 144 * (Scr/0.7)^-1.209 * 0.993^age (Scr >0.7 mg/dL) for female participants and eGFRcr mL/min/1.73m^2 = 141 x (Scr/0.9)^-0.411 x 0.993^age (Scr =<0.9 mg/dL) and eGFRcr mL/min/1.73m^2 = 141 * (Scr/0.9)^-1.209 x 0.993^age (Scr >0.9 mg/dL) for male participants. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Median | Full Range | mL/min/1.73 m^2 | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine by Cockcroft-Gault Formula | Change from reference in eGFRcr by cockcroft-gault formula was reported. The eGFRcr was assessed by calculated creatinine clearance (CrCl) using the Cockcroft-Gault formula, and was assessed using CrCl [mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit (kilogram [kg]), C is the serum concentration of creatinine [mg/dL], R = 1 if the participant is male and = 0.85 if female. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Median | Full Range | mL/min | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula | Change from reference in eGFRcyst was calculated using the CKD-EPI equation as per Stage 1 (normal or high GFR) to Stage 5 (End Stage of CKD): <15 mL/min indicate very severe or end stage kidney failure. The eGFRcyst was assessed by calculated serum cystatin C (Scyst) using the CKD-EPI equation: eGFRcyst mL/min/1.73m^2 = 133 * (Scyst/0,8)^-0.499 * 0.996^age [x 0.932 if female] (Scyst =<0.8 mg/L) and eGFRcr mL/min/1.73m^2 = 133 * (Scyst/0,8)^-1.328 * 0.996^age [* 0.932 if male] (Scyst >0.8 mg/L). Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Median | Full Range | mL/min/1.73 m^2 | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Change From Reference in UPCR | Change from reference in UPCR was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Median | Full Range | mg/g | | From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | |
|
| Secondary | Change From Reference in UACR | Change from reference in UACR at Week 96 was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Median | Full Range | mg/g | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | |
|
| Secondary | Change From Reference in URBPCR | Change from reference in URBPCR at Week 96 were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Median | Full Range | mcg/g | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Change From Reference in UB2MGCR | Change from reference in UB2MGCR was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Median | Full Range | mcg/g | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | |
|
| Secondary | Percent Change From Reference in Urine FEPO4 | Percent change from reference in FEPO4 at Week 96 were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Median | Full Range | Percent change in urine FEPO4 | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Percent Change From Reference in Hip and Spine BMD | The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by DEXA scan. Positive values are "best values" and negative values are "worst values" of change. Percent change from reference in hip and spine BMD was assessed. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The analysis population is BIS. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and 'n' (number analyzed) signifies participants analyzed for this outcome measure at specified category. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Mean | Standard Error | Percent change in BMD | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Change From Reference in BMD T-score of Hip and Spine at Week 96 | BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The analysis set of BIS. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and n (number analyzed) signifies participants analyzed for this endpoint at specified category. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Mean | Standard Error | BMD T-score | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Change From Reference in ALP Levels | Change from reference in ALP levels at Week 96 was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | The analysis population is BIS. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Mean | Standard Error | U/L | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | Switch to D/C/F/TAF |
|
| Secondary | Change From Reference in Levels of Serum P1NP | Change from reference in serum P1NP levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Mean | Standard Error | mcg/L | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Change From Reference in Levels of Serum CTX | Change from reference in serum CTX levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Mean | Standard Error | mcg/L | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Change From Reference in Levels of PTH | Change from reference in PTH levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Mean | Standard Error | pmol/L | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Change From Reference in Levels of 25-OH Vitamin D | Change from reference in 25-OH Vitamin D were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. | BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure. This outcome measure was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group. | Posted | | Mean | Standard Error | nmol/L | | From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
|
| Secondary | Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension | Percentage of participants with HIV RNA <50, <20, and <200 copies/mL post Week 96 to end of extension were reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure and n (number analyzed) signifies participants analyzed for this outcome measure at specified category. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 96 to end of extension (up to 3 years) | | | | ID | Title | Description |
|---|
| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | Switch to D/C/F/TAF |
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| Secondary | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) | Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). | The analysis population is ITT. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. Participants received treatment from baseline till Week 48/Switch in control arm and from switch till Week 96 in Switch to D/C/F/TAF arm. Therefore, Week 96 and Week 48 data was not collected for both arms at respective timepoints. | Posted | | Number | | percentage of participants | | From Baseline up to Week 96 | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Percentage of Participants With PDVF Post-week 96 to End of Extension | Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here N (number of participants analyzed) refers to 311 for test group and 310 for switch to D/C/F/TAFgroup in below table. | Posted | | Number | | percentage of participants | | Week 96 to end of extension (up to 3 years) | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates | Percentage of participants with non-PDVF by Kaplan-Meier Estimates were reported. PDVF was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From Week 96 to end of extension (up to 2 years and 6 months) | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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| Secondary | Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates | Percentage of participants with time to treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic failure or having discontinued for reasons other than alternate access to D/C/F/TAF (or other ARVs). | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From Week 96 to end of extension (up to 3 years) | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 |
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| Secondary | CD4+ Cell Count Post-Week From 96 to End of Extension | The immunologic change was determined by Cluster of CD4+ cell count. CD4+ cell count post-Week 96 to end of extension were assessed. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this outcome measure and n (number analyzed) signifies participants analyzed for this outcome measure at specified category. | Posted | | Mean | Standard Error | cells/mm^3 | | Week 96 to end of extension (up to 3 years) | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | Switch to D/C/F/TAF | |
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| Secondary | Number of Participants With ARV Resistance | Number of participants with DRV, FTC, TDF/TAF resistance were reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies total number of participants with screening/baseline and endpoint genotype. | Posted | | Count of Participants | | Participants | | Baseline to end of extension (up to 4 years) | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. | | OG001 | DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | Participants received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). |
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| Secondary | Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension | AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | | Number | | percentage of participants | | From Week 96 to end of extension (up to 3 years) | | | | ID | Title | Description |
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| OG000 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | Participants received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last participant has reached Week 48). After Week 48 analysis unblinding visit, all participants received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available. |
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