Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects (NCT NCT02431247)

Last Updated: 2022-09-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

725 participants

Primary outcome timeframe

At Week 48

Results posted on

2022-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	D/C/F/TAF (Test) (Baseline [BL] 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.	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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
BL to EOE-Test and BL to Switch- Control STARTED	362	363	0
BL to EOE-Test and BL to Switch- Control COMPLETED	296	322	0
BL to EOE-Test and BL to Switch- Control NOT COMPLETED	66	41	0
Switch to D/C/F/TAF (Until EOE) STARTED	0	0	322
Switch to D/C/F/TAF (Until EOE) COMPLETED	0	0	289
Switch to D/C/F/TAF (Until EOE) NOT COMPLETED	0	0	33

Reasons for withdrawal

Reasons for withdrawal
Measure	D/C/F/TAF (Test) (Baseline [BL] 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.	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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
BL to EOE-Test and BL to Switch- Control Other	11	2	0
BL to EOE-Test and BL to Switch- Control Lost to Follow-up	17	8	0
BL to EOE-Test and BL to Switch- Control Physician Decision	9	4	0
BL to EOE-Test and BL to Switch- Control Pregnancy	1	1	0
BL to EOE-Test and BL to Switch- Control Adverse Event	12	16	0
BL to EOE-Test and BL to Switch- Control Death	0	1	0
BL to EOE-Test and BL to Switch- Control Withdrawal by Subject	14	9	0
BL to EOE-Test and BL to Switch- Control Subject non-compliant	2	0	0
Switch to D/C/F/TAF (Until EOE) Other	0	0	4
Switch to D/C/F/TAF (Until EOE) Lost to Follow-up	0	0	12
Switch to D/C/F/TAF (Until EOE) Physician Decision	0	0	1
Switch to D/C/F/TAF (Until EOE) Adverse Event	0	0	5
Switch to D/C/F/TAF (Until EOE) Death	0	0	1
Switch to D/C/F/TAF (Until EOE) Withdrawal by Subject	0	0	10

Baseline Characteristics

A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=363 Participants 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).	Total n=725 Participants Total of all reporting groups
Age, Continuous	34 years n=5 Participants	34 years n=7 Participants	34.0 years n=5 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Adults (18-64 years)	362 Participants n=5 Participants	362 Participants n=7 Participants	724 Participants n=5 Participants
Age, Customized From 65 to 84 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	41 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	318 Participants n=5 Participants	322 Participants n=7 Participants	640 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized Other	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	258 Participants n=5 Participants	260 Participants n=7 Participants	518 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 48

Population: 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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=363 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
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	91.4 percentage of participants 95% Confidence Interval 88.1 • Interval 88.1 to 94.1	88.4 percentage of participants 95% Confidence Interval 84.7 • Interval 84.7 to 91.5	—

SECONDARY outcome

Timeframe: At Weeks 48 and 96

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=363 Participants 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).	Switch to D/C/F/TAF n=291 Participants After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach At week 48: <20 Copies per mL	82.6 percentage of participants Interval 78.3 to 86.4	79.3 percentage of participants Interval 74.8 to 83.4	—
Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach At week 48: <200 Copies per mL	92.8 percentage of participants Interval 89.7 to 95.3	90.6 percentage of participants Interval 87.2 to 93.4	—
Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach At week 96: <20 Copies per mL	76.2 percentage of participants Interval 71.5 to 80.5	—	83.5 percentage of participants Interval 78.7 to 87.6
Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach At week 96: <200 Copies per mL	86.2 percentage of participants Interval 82.2 to 89.6	—	96.9 percentage of participants Interval 94.2 to 98.6

SECONDARY outcome

Timeframe: At Week 48 and 96

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=363 Participants 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).	Switch to D/C/F/TAF n=291 Participants After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
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 At Week 48: < 20 Copies per mL	82.6 percentage of participants Interval 78.3 to 86.4	79.9 percentage of participants Interval 75.4 to 83.9	—
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 At Week 48: <50 Copies per mL	91.2 percentage of participants Interval 87.8 to 93.9	88.7 percentage of participants Interval 85.0 to 91.8	—
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 At Week 48: <200 Copies per mL	93.1 percentage of participants Interval 90.0 to 95.5	91.7 percentage of participants Interval 88.4 to 94.4	—
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 At Week 96: <20 Copies per mL	73.2 percentage of participants Interval 68.3 to 77.7	—	78.4 percentage of participants Interval 73.2 to 82.9
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 At Week 96: <50 Copies per mL	85.1 percentage of participants Interval 81.0 to 88.6	—	93.8 percentage of participants Interval 90.4 to 96.3
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 At Week 96: <200 Copies per mL	86.7 percentage of participants Interval 82.8 to 90.1	—	96.9 percentage of participants Interval 94.2 to 98.6

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: 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).

Change from baseline in log10 HIV-1 RNA levels were reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=363 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in log10 HIV-1 RNA Levels at Week 48	-2.95 log10 HIV-1 RNA copies per mL Standard Error 0.044 • Interval 0.044 to	-2.91 log10 HIV-1 RNA copies per mL Standard Error 0.044 • Interval 0.044 to	—

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=363 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48	190.49 Cells per millimeter cube (cells/mm^3) Standard Error 10.472 • Interval 10.472 to	172.01 Cells per millimeter cube (cells/mm^3) Standard Error 10.458 • Interval 10.458 to	—

SECONDARY outcome

Timeframe: Baseline and Week 48

Change from baseline in serum creatinine at Week 48 was reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=340 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=330 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Serum Creatinine at Week 48	0.05 milligram per deciliter (mg/dL) Standard Error 0.006 • Interval 0.006 to	0.09 milligram per deciliter (mg/dL) Standard Error 0.006 • Interval 0.006 to	—

SECONDARY outcome

Timeframe: Baseline and 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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=340 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=330 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
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	-6.04 mL/min/1.73 m^2 Standard Error 0.551 • Interval 0.551 to	-9.16 mL/min/1.73 m^2 Standard Error 0.559 • Interval 0.559 to	—

SECONDARY outcome

Timeframe: Baseline and 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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=340 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=330 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine by (Cockcroft-Gault Formula) at Week 48	-5.16 milliliter per minute (mL/min) Standard Error 0.790 • Interval 0.79 to	-11.20 milliliter per minute (mL/min) Standard Error 0.802 • Interval 0.802 to	—

SECONDARY outcome

Timeframe: Baseline and 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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=337 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=329 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula at Week 48	5.32 mL/min/1.73 m^2 Standard Error 0.525 • Interval 0.525 to	2.92 mL/min/1.73 m^2 Standard Error 0.532 • Interval 0.532 to	—

SECONDARY outcome

Timeframe: Up to Weeks 48

Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=363 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
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 Grade 3 AEs	4.7 percentage of participants	4.4 percentage of participants	—
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 Grade 4 AEs	0.6 percentage of participants	1.7 percentage of participants	—
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 SAEs	4.7 percentage of participants	5.8 percentage of participants	—
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 Premature discontinuations due to AEs	1.9 percentage of participants	4.4 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 48

Change from baseline in UPCR at Week 48 was reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=336 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=325 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48	-15.72 milligram per gram (mg/g) Full Range -748.1 • Interval -748.1 to 254.2	-10.53 milligram per gram (mg/g) Full Range -903.0 • Interval -903.0 to 1546.1	—

SECONDARY outcome

Timeframe: Baseline and Week 48

Change from baseline in UACR at Week 48 was reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=338 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=327 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48	-0.58 mg/g Full Range -226.5 • Interval -226.5 to 143.8	-0.15 mg/g Full Range -640.4 • Interval -640.4 to 969.6	—

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: 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.

Change from baseline in URBPCR at Week 48 were reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=334 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=324 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48	7.00 microgram per gram (mcg/g) Full Range -1555.7 • Interval -1555.7 to 5183.8	35.02 microgram per gram (mcg/g) Full Range -700.7 • Interval -700.7 to 30350.2	—

SECONDARY outcome

Timeframe: Baseline and Week 48

Change from baseline in UB2MGCR at Week 48 were reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=331 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=320 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48	-30.42 mcg/g Full Range -11818.6 • Interval -11818.6 to 3452.0	18.36 mcg/g Full Range -2440.5 • Interval -2440.5 to 90832.0	—

SECONDARY outcome

Timeframe: Baseline and Week 48

Percent change from baseline in FEPO4 at Week 48 was reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=339 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=329 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48	16.00 Percent change Full Range -87.3 • Interval -87.3 to 1756.6	22.55 Percent change Full Range -90.1 • Interval -90.1 to 1720.7	—

SECONDARY outcome

Timeframe: 0 to 24 hours post dose

Population: 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.

AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post-dose.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=355 Participants 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.	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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir	87909.3282 hoursnanogram per milliliter (hng/mL) Standard Deviation 20232.09905	—	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=355 Participants 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.	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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Predose (Trough) Plasma Concentration (C0h) of Darunavir	1898.9100 nanogram per milliliter (ng/mL) Standard Deviation 758.83837	—	—

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=355 Participants 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.	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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide	132.3117 h*ng/mL Standard Deviation 40.87742	—	—

SECONDARY outcome

Timeframe: 0 to 2 hours post dose

Population: 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.

C0-2h is defined as the plasma concentrations 2 hours after dosing.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=355 Participants 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.	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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Plasma Concentrations 2 Hours After Dosing (C0-2h) of Tenofovir Alafenamide	11.9785 ng/mL Standard Deviation 11.86104	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=113 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=99 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD) Hip region BMD (Week 24)	0.29 Percent change Standard Error 0.248	-1.66 Percent change Standard Error 0.269	—
Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD) Spine region BMD (Week 24)	-1.34 Percent change Standard Error 0.285	-3.43 Percent change Standard Error 0.309	—
Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD) Hip region BMD (Week 48)	0.17 Percent change Standard Error 0.322	-2.69 Percent change Standard Error 0.342	—
Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD) Spine region BMD (Week 48)	-0.68 Percent change Standard Error 0.402	-2.38 Percent change Standard Error 0.428	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=113 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=99 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in BMD T-score of Hip and Spine Hip region BMD T-score (Week 24)	0.019 BMD T-score Standard Error 0.0180	-0.109 BMD T-score Standard Error 0.0157	—
Change From Baseline in BMD T-score of Hip and Spine Spine region BMD T-score (Week 24)	-0.121 BMD T-score Standard Error 0.0259	-0.322 BMD T-score Standard Error 0.0307	—
Change From Baseline in BMD T-score of Hip and Spine Hip region BMD T-score (Week 48)	0.015 BMD T-score Standard Error 0.0213	-0.177 BMD T-score Standard Error 0.0225	—
Change From Baseline in BMD T-score of Hip and Spine Spine region BMD T-score (Week 48)	-0.061 BMD T-score Standard Error 0.0390	-0.225 BMD T-score Standard Error 0.0386	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Change from baseline in ALP at Weeks 24 and 48 was reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=113 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=99 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Alkaline Phosphatase (ALP) Levels at Weeks 24 and 48 Week 24	-3.2 Units per liter (U/L) Standard Error 1.17	12.0 Units per liter (U/L) Standard Error 1.74	—
Change From Baseline in Alkaline Phosphatase (ALP) Levels at Weeks 24 and 48 Week 48	-1.1 Units per liter (U/L) Standard Error 1.29	15.1 Units per liter (U/L) Standard Error 2.00	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Change from baseline in serum P1NP at Weeks 24 and 48 were reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=113 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=99 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Weeks 24 and 48 Week 24	1.892 microgram per liter (mcg/L) Standard Error 1.3754	24.679 microgram per liter (mcg/L) Standard Error 2.0956	—
Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Weeks 24 and 48 Week 48	0.065 microgram per liter (mcg/L) Standard Error 1.6428	24.251 microgram per liter (mcg/L) Standard Error 2.6337	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Change from baseline in serum CTX at Weeks 24 and 48 were reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=113 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=99 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Weeks 24 and 48 Week 24	0.047 mcg/L Standard Error 0.0165	0.283 mcg/L Standard Error 0.0251	—
Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Weeks 24 and 48 Week 48	0.046 mcg/L Standard Error 0.0174	0.226 mcg/L Standard Error 0.0234	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Population: 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.

Change from baseline in PTH at Weeks 24 and 48 were reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=113 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=99 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Levels of Parathyroid Hormone (PTH) at Weeks 24 and 48 Week 24	0.113 Picomol per liter (pmol/L) Standard Error 0.2171	0.777 Picomol per liter (pmol/L) Standard Error 0.2401	—
Change From Baseline in Levels of Parathyroid Hormone (PTH) at Weeks 24 and 48 Week 48	-0.004 Picomol per liter (pmol/L) Standard Error 0.2232	0.633 Picomol per liter (pmol/L) Standard Error 0.2155	—

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Change from baseline in 25-OH Vitamin D levels at Week 24 and 48 were reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=113 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=99 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48 Week 24	12.7 nanomol per liter (nmol/L) Standard Error 2.76	22.1 nanomol per liter (nmol/L) Standard Error 3.76	—
Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48 Week 48	16.9 nanomol per liter (nmol/L) Standard Error 2.84	28.3 nanomol per liter (nmol/L) Standard Error 3.15	—

SECONDARY outcome

Timeframe: At Week 96

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=291 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percentage of Participants With HIV-1 RNA <50 Copies Per mL at Week 96 Defined by FDA Snapshot Approach	85.1 percentage of participants 95% Confidence Interval 81.0 • Interval 81.0 to 88.6	94.2 percentage of participants 95% Confidence Interval 90.8 • Interval 90.8 to 96.6	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=289 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in log10 HIV-1 RNA Levels at Week 96	-2.72 log10 HIV-1 RNA copies per mL Standard Error 0.0614	-0.0027 log10 HIV-1 RNA copies per mL Standard Error 0.0131	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=289 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in CD4+ Cell Count at Week 96	228.85 cells/mm^3 Standard Error 11.951 • Interval 11.951 to	27.01 cells/mm^3 Standard Error 9.522 • Interval 9.522 to	—

SECONDARY outcome

Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=289 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=282 Participants 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).	Switch to D/C/F/TAF n=222 Participants After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability Baseline to Switch (double-blind treatment)	87.2 percentage of participants	82.6 percentage of participants	—
Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability Switch to End of Extension (open-label D/C/F/TAF)	92.2 percentage of participants	—	88.7 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 96

Population: 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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=295 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
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 Grade 3 AEs	11.6 percentage of participants	3.7 percentage of participants	—
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 Grade 4 AEs	0.8 percentage of participants	1.4 percentage of participants	—
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 SAEs	10.8 percentage of participants	2.7 percentage of participants	—
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 Premature discontinuations due to AEs	2.8 percentage of participants	0.3 percentage of participants	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=317 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=287 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in Serum Creatinine	0.045 mg/dL Full Range -0.25 • Interval -0.25 to 0.3	-0.034 mg/dL Full Range -0.71 • Interval -0.71 to 0.4	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=317 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=287 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in eGFRcr by CKD-EPI Formula	-5.6 mL/min/1.73 m^2 Full Range -33 • Interval -33.0 to 29.0	2.3 mL/min/1.73 m^2 Full Range -29 • Interval -29.0 to 43.0	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=317 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=287 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine by Cockcroft-Gault Formula	-5.2 mL/min Full Range -73 • Interval -73.0 to 41.0	4.6 mL/min Full Range -47 • Interval -47.0 to 55.0	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=22 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=33 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula	4.4 mL/min/1.73 m^2 Full Range -14 • Interval -14.0 to 37.0	0 mL/min/1.73 m^2 Full Range -12 • Interval -12.0 to 26.0	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=312 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=282 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in UPCR	-15.46 mg/g Interval -728.7 to 197.9	-1.40 mg/g Interval -705.7 to 289.2	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=317 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=287 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in UACR	-0.70 mg/g Full Range -288.1 • Interval -288.1 to 44.5	-0.49 mg/g Full Range -294.5 • Interval -294.5 to 583.2	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=313 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=285 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in URBPCR	13.70 mcg/g Full Range -1555.1 • Interval -1555.1 to 2547.1	-35.53 mcg/g Full Range -108886.3 • Interval -108886.3 to 291.3	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=310 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=286 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in UB2MGCR	-27.04 mcg/g Full Range -11704.6 • Interval -11704.6 to 894.7	-40.53 mcg/g Full Range -111778.9 • Interval -111778.9 to 624.6	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=316 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=286 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percent Change From Reference in Urine FEPO4	18.52 Percent change in urine FEPO4 Full Range -84.2 • Interval -84.2 to 1170.1	-7.51 Percent change in urine FEPO4 Full Range -83.5 • Interval -83.5 to 494.7	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=113 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=83 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percent Change From Reference in Hip and Spine BMD Hip region BMD	-0.2565 Percent change in BMD Standard Error 0.35599	0.5467 Percent change in BMD Standard Error 0.38512	—
Percent Change From Reference in Hip and Spine BMD Spine region BMD	-0.9349 Percent change in BMD Standard Error 0.44599	0.4829 Percent change in BMD Standard Error 0.39270	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=87 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=71 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in BMD T-score of Hip and Spine at Week 96 Hip region BMD T-score	-0.016 BMD T-score Standard Error 0.0245	0.025 BMD T-score Standard Error 0.0272	—
Change From Reference in BMD T-score of Hip and Spine at Week 96 Spine region BMD T-score	-0.090 BMD T-score Standard Error 0.0407	0.034 BMD T-score Standard Error 0.0355	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=92 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=80 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in ALP Levels	-0.9 U/L Standard Error 1.23 • Interval 1.23 to	-9.7 U/L Standard Error 1.55 • Interval 1.55 to	—

SECONDARY outcome

Timeframe: 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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=91 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=75 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in Levels of Serum P1NP	2.817 mcg/L Standard Error 1.7140	-11.963 mcg/L Standard Error 1.7636	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=91 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=77 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in Levels of Serum CTX	0.041 mcg/L Standard Error 0.0190 • Interval 0.019 to	-0.162 mcg/L Standard Error 0.0190 • Interval 0.019 to	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=90 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=77 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in Levels of PTH	-0.290 pmol/L Standard Error 0.2078 • Interval 0.2078 to	-1.283 pmol/L Standard Error 0.2483 • Interval 0.2483 to	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=91 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=77 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Change From Reference in Levels of 25-OH Vitamin D	21.3 nmol/L Standard Error 2.45 • Interval 2.45 to	-10.3 nmol/L Standard Error 2.87 • Interval 2.87 to	—

SECONDARY outcome

Timeframe: Week 96 to end of extension (up to 3 years)

Population: 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.

Percentage of participants with HIV RNA \<50, \<20, and \<200 copies/mL post Week 96 to end of extension were reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=303 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=296 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 6 months (<50 copies/mL)	97.7 percentage of participants Interval 95.3 to 99.1	96.3 percentage of participants Interval 93.4 to 98.1	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 12 months (<50 copies/mL)	99.0 percentage of participants Interval 96.3 to 99.9	96.7 percentage of participants Interval 93.4 to 98.7	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 18 months (<50 copies/mL)	98.1 percentage of participants Interval 94.6 to 99.6	98.2 percentage of participants Interval 94.8 to 99.6	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 24 months (<50 copies/mL)	97.5 percentage of participants Interval 91.4 to 99.7	95.7 percentage of participants Interval 89.2 to 98.8	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 30 months (<50 copies/mL)	94.7 percentage of participants Interval 85.4 to 98.9	91.4 percentage of participants Interval 81.0 to 97.1	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 36 months (<50 copies/mL)	100.0 percentage of participants Interval 82.4 to 100.0	68.8 percentage of participants Interval 41.3 to 89.0	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 6 months (<20 copies/mL)	85.8 percentage of participants Interval 81.4 to 89.5	88.2 percentage of participants Interval 83.9 to 91.6	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 12 months (<20 copies/mL)	89.7 percentage of participants Interval 84.5 to 93.6	91.6 percentage of participants Interval 87.0 to 94.9	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 18 months (<20 copies/mL)	92.4 percentage of participants Interval 87.1 to 96.0	92.8 percentage of participants Interval 87.8 to 96.2	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 24 months (<20 copies/mL)	90.1 percentage of participants Interval 81.5 to 95.6	87.0 percentage of participants Interval 78.3 to 93.1	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 30 months (<20 copies/mL)	89.5 percentage of participants Interval 78.5 to 96.0	84.5 percentage of participants Interval 72.6 to 92.7	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 36 months (<20 copies/mL)	94.7 percentage of participants Interval 74.0 to 99.9	62.5 percentage of participants Interval 35.4 to 84.8	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 6 months (<200 copies/mL)	99.7 percentage of participants Interval 98.2 to 100.0	99.3 percentage of participants Interval 97.6 to 99.9	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 12 months (<200 copies/mL)	100.0 percentage of participants Interval 98.1 to 100.0	99.5 percentage of participants Interval 97.4 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 18 months (<200 copies/mL)	98.7 percentage of participants Interval 95.5 to 99.8	98.2 percentage of participants Interval 94.8 to 99.6	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 24 months (<200 copies/mL)	97.5 percentage of participants Interval 91.4 to 99.7	97.8 percentage of participants Interval 92.4 to 99.7	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 30 months (<200 copies/mL)	96.5 percentage of participants Interval 87.9 to 99.6	98.3 percentage of participants Interval 90.8 to 100.0	—
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension Week 96 + 36 months (<200 copies/mL)	100.0 percentage of participants Interval 82.4 to 100.0	87.5 percentage of participants Interval 61.7 to 98.4	—

SECONDARY outcome

Timeframe: From Baseline up to Week 96

Population: 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.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=362 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=363 Participants 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).	Switch to D/C/F/TAF n=295 Participants After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Participants who met PDVF (Baseline - Week 96)	4.1 percentage of participants	—	—
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Virologic non-response (Baseline - Week 96)	0.6 percentage of participants	—	—
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Virologic rebound (Baseline-Week 96)	0.3 percentage of participants	—	—
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Viremic at final time point (Baseline-Week 96)	0.6 percentage of participants	—	—
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Participants who met PDVF (Baseline - Switch)	—	4.4 percentage of participants	—
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Virologic non-response (Baseline - Switch)	—	0 percentage of participants	—
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Virologic rebound (Baseline - Switch)	—	3.9 percentage of participants	—
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Viremic at final time point (Baseline - Switch)	—	0.6 percentage of participants	—
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Participants who met PDVF (Switch - Week 96)	—	—	1.1 percentage of participants
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Virologic non-response (Switch - Week 96)	—	—	0 percentage of participants
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Virologic rebound (Switch - Week 96)	—	—	1.1 percentage of participants
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) Viremic at final time point (Switch - Week 96)	—	—	0 percentage of participants

SECONDARY outcome

Timeframe: Week 96 to end of extension (up to 3 years)

Population: 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.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=311 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=310 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percentage of Participants With PDVF Post-week 96 to End of Extension Participants who met PDVF	1.0 percentage of participants	2.1 percentage of participants	—
Percentage of Participants With PDVF Post-week 96 to End of Extension Virologic non-response	0 percentage of participants	0 percentage of participants	—
Percentage of Participants With PDVF Post-week 96 to End of Extension Virologic rebound	1.0 percentage of participants	1.4 percentage of participants	—
Percentage of Participants With PDVF Post-week 96 to End of Extension Viremic at final time point	0 percentage of participants	0.7 percentage of participants	—

SECONDARY outcome

Timeframe: From Week 96 to end of extension (up to 2 years and 6 months)

Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=311 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=310 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates Week 96	100 percentage of participants Interval 100.0 to 100.0	100 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates Week 96 + 6 months	99.6 percentage of participants Interval 97.2 to 99.9	99.2 percentage of participants Interval 97.0 to 99.8	—
Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates Week 96 + 12 months	99.6 percentage of participants Interval 97.2 to 99.9	99.2 percentage of participants Interval 97.0 to 99.8	—
Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates Week 96 + 18 months	98.6 percentage of participants Interval 94.0 to 99.7	97.8 percentage of participants Interval 94.1 to 99.2	—
Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates Week 96 + 24 months	97.3 percentage of participants Interval 91.0 to 99.2	97.8 percentage of participants Interval 94.1 to 99.2	—
Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates Week 96 + 30 months	97.3 percentage of participants Interval 91.0 to 99.2	92.5 percentage of participants Interval 79.8 to 97.3	—

SECONDARY outcome

Timeframe: From Week 96 to end of extension (up to 3 years)

Population: 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.

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).

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=311 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=310 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates Week 96	100 percentage of participants Interval 100.0 to 100.0	100 percentage of participants Interval 100.0 to 100.0	—
Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates Week 96 + 6 months	98.9 percentage of participants Interval 96.5 to 99.6	97.4 percentage of participants Interval 94.5 to 98.7	—
Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates Week 96 + 12 months	95.6 percentage of participants Interval 91.7 to 97.7	94.1 percentage of participants Interval 90.2 to 96.5	—
Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates Week 96 + 18 months	90.6 percentage of participants Interval 84.9 to 94.2	89.5 percentage of participants Interval 84.3 to 93.0	—
Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates Week 96 + 24 months	87.1 percentage of participants Interval 79.8 to 91.8	86.4 percentage of participants Interval 80.0 to 90.9	—
Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates Week 96 + 30 months	84.8 percentage of participants Interval 75.8 to 90.6	79.1 percentage of participants Interval 68.9 to 86.3	—
Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates Week 96 + 36 months	84.8 percentage of participants Interval 75.8 to 90.6	—	—

SECONDARY outcome

Timeframe: Week 96 to end of extension (up to 3 years)

The immunologic change was determined by Cluster of CD4+ cell count. CD4+ cell count post-Week 96 to end of extension were assessed.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=300 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=293 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
CD4+ Cell Count Post-Week From 96 to End of Extension Week 96 + 6 months	790.2 cells/mm^3 Standard Error 17.23	749.7 cells/mm^3 Standard Error 16.44	—
CD4+ Cell Count Post-Week From 96 to End of Extension Week 96 + 12 months	779.4 cells/mm^3 Standard Error 22.45	774.3 cells/mm^3 Standard Error 21.91	—
CD4+ Cell Count Post-Week From 96 to End of Extension Week 96 + 18 months	789.8 cells/mm^3 Standard Error 23.43	758.4 cells/mm^3 Standard Error 23.25	—
CD4+ Cell Count Post-Week From 96 to End of Extension Week 96 + 24 months	781.9 cells/mm^3 Standard Error 37.77	784.1 cells/mm^3 Standard Error 30.78	—
CD4+ Cell Count Post-Week From 96 to End of Extension Week 96 + 30 months	741.6 cells/mm^3 Standard Error 37.12	736.7 cells/mm^3 Standard Error 37.47	—
CD4+ Cell Count Post-Week From 96 to End of Extension Week 96 + 36 months	784.7 cells/mm^3 Standard Error 69.74	778.4 cells/mm^3 Standard Error 86.59	—

SECONDARY outcome

Timeframe: Baseline to end of extension (up to 4 years)

Number of participants with DRV, FTC, TDF/TAF resistance were reported.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=12 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=8 Participants 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).	Switch to D/C/F/TAF n=7 Participants After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Number of Participants With ARV Resistance DRV resistance-associated mutations (RAMs)	0 Participants	0 Participants	0 Participants
Number of Participants With ARV Resistance TFV RAMs	0 Participants	0 Participants	0 Participants
Number of Participants With ARV Resistance FTC RAMs	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From Week 96 to end of extension (up to 3 years)

Population: The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.

Outcome measures

Outcome measures
Measure	D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) n=311 Participants 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=310 Participants 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).	Switch to D/C/F/TAF After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension Grade 3 AEs	3.5 percentage of participants	5.2 percentage of participants	—
Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension Grade 4 AEs	0 percentage of participants	1.3 percentage of participants	—
Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension SAEs	3.2 percentage of participants	4.8 percentage of participants	—
Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension Premature discontinuations due to AEs	1.0 percentage of participants	1.3 percentage of participants	—

Adverse Events

D/C/F/TAF+ FTC/TDF (Test)

Serious events: 47 serious events

Other events: 284 other events

Deaths: 0 deaths

DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)

Serious events: 36 serious events

Other events: 252 other events

Deaths: 1 deaths

Switch to D/C/F/TAF Group

Serious events: 21 serious events

Other events: 137 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Registry Group

Janssen Sciences Ireland UC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Measure	D/C/F/TAF+ FTC/TDF (Test) n=362 participants at risk 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.	DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) n=363 participants at risk 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).	Switch to D/C/F/TAF Group n=322 participants at risk After Week 48 analysis unblinding visit, participants earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, participants were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
Infections and infestations Nasopharyngitis	17.7% 64/362 • Number of events 102 • Up to 60 months 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.	10.5% 38/363 • Number of events 58 • Up to 60 months 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.	5.9% 19/322 • Number of events 23 • Up to 60 months 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.
Infections and infestations Pharyngitis	8.6% 31/362 • Number of events 34 • Up to 60 months 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.	5.2% 19/363 • Number of events 24 • Up to 60 months 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.	2.2% 7/322 • Number of events 7 • Up to 60 months 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.
Infections and infestations Respiratory Tract Infection	5.5% 20/362 • Number of events 28 • Up to 60 months 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.	3.9% 14/363 • Number of events 22 • Up to 60 months 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.	2.5% 8/322 • Number of events 11 • Up to 60 months 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.
Infections and infestations Syphilis	11.3% 41/362 • Number of events 51 • Up to 60 months 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.	6.9% 25/363 • Number of events 29 • Up to 60 months 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.	7.5% 24/322 • Number of events 27 • Up to 60 months 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.
Infections and infestations Upper Respiratory Tract Infection	11.0% 40/362 • Number of events 55 • Up to 60 months 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.	8.3% 30/363 • Number of events 42 • Up to 60 months 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.	8.1% 26/322 • Number of events 43 • Up to 60 months 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.
Gastrointestinal disorders Diarrhoea	24.6% 89/362 • Number of events 143 • Up to 60 months 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.	19.8% 72/363 • Number of events 91 • Up to 60 months 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.	5.6% 18/322 • Number of events 20 • Up to 60 months 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.
Gastrointestinal disorders Nausea	9.4% 34/362 • Number of events 39 • Up to 60 months 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.	12.7% 46/363 • Number of events 56 • Up to 60 months 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.	2.5% 8/322 • Number of events 8 • Up to 60 months 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.
General disorders Asthenia	5.8% 21/362 • Number of events 21 • Up to 60 months 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.	4.1% 15/363 • Number of events 16 • Up to 60 months 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.	1.2% 4/322 • Number of events 4 • Up to 60 months 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.
General disorders Fatigue	7.2% 26/362 • Number of events 29 • Up to 60 months 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.	5.8% 21/363 • Number of events 24 • Up to 60 months 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.	0.31% 1/322 • Number of events 1 • Up to 60 months 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.
General disorders Pyrexia	5.5% 20/362 • Number of events 22 • Up to 60 months 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.	6.6% 24/363 • Number of events 28 • Up to 60 months 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.	1.9% 6/322 • Number of events 6 • Up to 60 months 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.
Infections and infestations Bronchitis	6.6% 24/362 • Number of events 32 • Up to 60 months 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.	6.9% 25/363 • Number of events 30 • Up to 60 months 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.	6.2% 20/322 • Number of events 22 • Up to 60 months 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.
Infections and infestations Chlamydial Infection	6.4% 23/362 • Number of events 27 • Up to 60 months 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.	2.5% 9/363 • Number of events 9 • Up to 60 months 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.	0.62% 2/322 • Number of events 2 • Up to 60 months 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.
Infections and infestations Gastroenteritis	7.7% 28/362 • Number of events 32 • Up to 60 months 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.	4.1% 15/363 • Number of events 15 • Up to 60 months 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.	1.6% 5/322 • Number of events 5 • Up to 60 months 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.
Infections and infestations Gonorrhoea	5.8% 21/362 • Number of events 31 • Up to 60 months 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.	3.9% 14/363 • Number of events 15 • Up to 60 months 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.	1.6% 5/322 • Number of events 6 • Up to 60 months 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.
Metabolism and nutrition disorders Vitamin D Deficiency	7.7% 28/362 • Number of events 32 • Up to 60 months 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.	4.4% 16/363 • Number of events 16 • Up to 60 months 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.	1.9% 6/322 • Number of events 6 • Up to 60 months 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.
Musculoskeletal and connective tissue disorders Arthralgia	5.5% 20/362 • Number of events 25 • Up to 60 months 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.	4.7% 17/363 • Number of events 20 • Up to 60 months 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.	3.4% 11/322 • Number of events 12 • Up to 60 months 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.
Musculoskeletal and connective tissue disorders Back Pain	8.6% 31/362 • Number of events 36 • Up to 60 months 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.	2.8% 10/363 • Number of events 11 • Up to 60 months 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.	5.0% 16/322 • Number of events 18 • Up to 60 months 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.
Musculoskeletal and connective tissue disorders Osteopenia	5.2% 19/362 • Number of events 20 • Up to 60 months 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.	8.0% 29/363 • Number of events 32 • Up to 60 months 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.	0.00% 0/322 • Up to 60 months 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.
Nervous system disorders Headache	15.5% 56/362 • Number of events 79 • Up to 60 months 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.	10.5% 38/363 • Number of events 66 • Up to 60 months 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.	3.4% 11/322 • Number of events 12 • Up to 60 months 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.
Psychiatric disorders Anxiety	5.2% 19/362 • Number of events 21 • Up to 60 months 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.	2.5% 9/363 • Number of events 10 • Up to 60 months 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.	1.6% 5/322 • Number of events 5 • Up to 60 months 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.
Psychiatric disorders Insomnia	5.5% 20/362 • Number of events 24 • Up to 60 months 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.	3.6% 13/363 • Number of events 14 • Up to 60 months 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.	1.6% 5/322 • Number of events 5 • Up to 60 months 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.
Respiratory, thoracic and mediastinal disorders Cough	5.5% 20/362 • Number of events 24 • Up to 60 months 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.	4.1% 15/363 • Number of events 16 • Up to 60 months 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.	2.2% 7/322 • Number of events 7 • Up to 60 months 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.
Skin and subcutaneous tissue disorders Rash	10.2% 37/362 • Number of events 44 • Up to 60 months 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.	6.9% 25/363 • Number of events 26 • Up to 60 months 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.	2.8% 9/322 • Number of events 9 • Up to 60 months 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.