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Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397694
Recruitment Status : Completed
First Posted : March 25, 2015
Results First Posted : March 27, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV-1 Infection
Interventions Drug: BIC
Drug: F/TAF
Drug: DTG
Drug: BIC Placebo
Drug: DTG Placebo
Drug: B/F/TAF
Enrollment 98
Recruitment Details Participants were enrolled at 22 centers in the United States of America.The first participant was screened on 23 March 2015 and the last study visit occurred on 27 February 2019.
Pre-assignment Details 125 participants were screened.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description Bictegravir (BIC) (75 mg) + emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) + dolutegravir (DTG) placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg). DTG (50 mg) + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
Period Title: Double-Blinded Phase
Started 65 33
Completed 62 30
Not Completed 3 3
Reason Not Completed
Adverse Event             1             0
Non-compliance with study drug             0             2
Withdrawal by Subject             1             0
Lost to Follow-up             1             1
Period Title: Open Label Extension Phase
Started 62 30
Completed 54 29
Not Completed 8 1
Reason Not Completed
Protocol Violation             1             0
Withdrew Consent             3             1
Lost to Follow-up             4             0
Arm/Group Title BIC + F/TAF DTG + F/TAF Total
Hide Arm/Group Description BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg). DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg). Total of all reporting groups
Overall Number of Baseline Participants 65 33 98
Hide Baseline Analysis Population Description
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 33 participants 98 participants
34  (11.4) 38  (12.9) 35  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 33 participants 98 participants
Female 1 3 4
Male 64 30 94
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 33 participants 98 participants
American Indian or Alaska Native 1 0 1
Asian 1 2 3
Black 24 12 36
Native Hawaiian or Pacific Islander 1 0 1
White 38 18 56
Other 0 1 1
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 33 participants 98 participants
Hispanic or Latino 11 4 15
Not Hispanic or Latino 54 29 83
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 65 participants 33 participants 98 participants
4.39  (0.764) 4.38  (0.866) 4.39  (0.795)
HIV-1 RNA category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 33 participants 98 participants
≤ 100,000 copies/mL 55 26 81
> 100,000 to ≤ 400,000 copies/mL 6 6 12
> 400,000 copies/mL 4 1 5
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/μL
Number Analyzed 65 participants 33 participants 98 participants
471  (190.9) 507  (271.0) 483  (220.3)
CD4 Cell Count Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 33 participants 98 participants
< 200 cells/μL 3 3 6
≥ 200 to < 350 cells/µL 17 8 25
≥ 350 to < 500 cells/µL 20 6 26
≥ 500 cells/µL 25 16 41
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, 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.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all participants who were randomized into the double-blinded phase of study and received at least 1 dose of study drug during the double-blinded phase.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 65 33
Measure Type: Number
Unit of Measure: percentage of participants
96.9 93.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BIC + F/TAF, DTG + F/TAF
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Noninferiority of treatment with BIC + F/TAF relative to treatment with DTG + F/TAF. Noninferiority assessed using a conventional 95% confidence interval (CI) approach, with a noninferiority margin of 12%
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel Haenszel test stratified by baseline HIV-1 RNA stratum (≤ 100,000 copies/mL vs > 100,000 copies/mL).
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-8.5 to 14.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the snapshot algorithm, 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 65 33
Measure Type: Number
Unit of Measure: percentage of participants
93.8 93.9
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48
Hide Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, 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.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 65 33
Measure Type: Number
Unit of Measure: percentage of participants
96.9 90.9
4.Secondary Outcome
Title The Change From Baseline in log10 HIV-1 RNA at Week 12
Hide Description [Not Specified]
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 64 31
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.03  (0.791) -3.15  (0.731)
5.Secondary Outcome
Title The Change From Baseline in log10 HIV-1 RNA at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 64 32
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.09  (0.740) -3.12  (0.757)
6.Secondary Outcome
Title The Change From Baseline in log10 HIV-1 RNA at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 63 32
Mean (Standard Deviation)
Unit of Measure: log10 copies/mL
-3.09  (0.752) -3.11  (0.852)
7.Secondary Outcome
Title The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12
Hide Description [Not Specified]
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 64 31
Mean (Standard Deviation)
Unit of Measure: CD4 Cell Count (/μL)
170  (150.0) 173  (220.5)
8.Secondary Outcome
Title The Change From Baseline in CD4+ Cell Count at Week 24
Hide Description [Not Specified]
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 64 32
Mean (Standard Deviation)
Unit of Measure: CD4 Cell Count (/μL)
190  (176.8) 155  (165.8)
9.Secondary Outcome
Title The Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 63 30
Mean (Standard Deviation)
Unit of Measure: CD4 Cell Count (/μL)
258  (221.7) 188  (238.7)
10.Secondary Outcome
Title Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase
Hide Description [Not Specified]
Time Frame First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take the study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
After participants completed their blinded treatment with DTG 50 mg + F/TAF 200/25 mg FDC + BIC placebo, they were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25).
Overall Number of Participants Analyzed 65 33
Measure Type: Number
Unit of Measure: percentage of participants
87.7 72.7
11.Secondary Outcome
Title Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase
Hide Description [Not Specified]
Time Frame First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take the study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
After participants completed their blinded treatment with DTG 50 mg + F/TAF 200/25 mg FDC + BIC placebo, they were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25).
Overall Number of Participants Analyzed 65 33
Measure Type: Number
Unit of Measure: percentage of participants
87.5 87.5
12.Secondary Outcome
Title PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State
Hide Description Cmax is the maximum observed plasma concentration of the drug.
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Substudy Analysis Set included all participants who (1) were randomized into the double-blinded phase of study, (2) were enrolled into the PK substudy, (3) received at least 1 dose of study drug during the double-blinded phase, and (4) had at least 1 nonmissing intensive PK concentration value.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 23 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
BIC Number Analyzed 23 participants 7 participants
9344.3  (2506.33) NA [1]   (NA)
FTC Number Analyzed 22 participants 7 participants
1919.1  (470.18) 2157.1  (486.44)
TAF Number Analyzed 23 participants 7 participants
249.1  (137.40) 260.8  (212.44)
TFV Number Analyzed 23 participants 7 participants
19.1  (4.50) 20.9  (8.16)
[1]
Participants did not receive BIC
13.Secondary Outcome
Title PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State
Hide Description Tmax was defined as the time to Cmax.
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 23 7
Median (Inter-Quartile Range)
Unit of Measure: hours
BIC
2.00
(1.50 to 3.00)
NA [1] 
(NA to NA)
FTC
1.50
(1.00 to 2.00)
1.50
(1.02 to 2.00)
TAF
1.00
(0.50 to 1.50)
1.00
(0.50 to 1.00)
TFV
1.50
(1.50 to 2.00)
2.00
(1.53 to 2.00)
[1]
Participants did not receive BIC
14.Secondary Outcome
Title PK Parameter:Ctau for BIC, FTC and TFV
Hide Description Ctau was defined as the observed drug concentration at the end of the dosing interval.
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 23 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
BIC 3508.6  (1288.85) NA [1]   (NA)
FTC 76.6  (26.35) 102.6  (57.60)
TFV 10.7  (2.65) 12.2  (5.02)
[1]
Participants did not receive BIC
15.Secondary Outcome
Title PK Parameter: AUCtau for BIC, FTC, TAF, and TFV
Hide Description AUCtau is defined as the area under the concentration-time curve of the drug over time.
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 23 7
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
BIC 139778.8  (37810.07) NA [1]   (NA)
FTC 11605.4  (3241.84) 14689.8  (5869.37)
TAF 247.4  (140.62) 245.6  (125.03)
TFV 316.0  (74.01) 369.4  (147.96)
[1]
Participants did not receive BIC
16.Secondary Outcome
Title PK Parameter: t1/2 of BIC, FTC, TAF, and TFV
Hide Description t1/2 was defined as the terminal elimination half-life of the drug
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set were analyzed.
Arm/Group Title BIC + F/TAF DTG + F/TAF
Hide Arm/Group Description:
BIC 75 mg + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (50/200/25 mg).
DTG 50 mg + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF (200/50/25 mg).
Overall Number of Participants Analyzed 23 7
Median (Inter-Quartile Range)
Unit of Measure: hours
BIC
16.73
(13.79 to 19.28)
NA [1] 
(NA to NA)
FTC
5.46
(5.19 to 6.11)
5.70
(5.3 to 6.38)
TAF
0.37
(0.28 to 0.49)
0.42
(0.40 to 0.45)
TFV
37.74
(28.26 to 48.40)
34.47
(31.97 to 47.57)
[1]
Participants did not receive BIC
Time Frame First dose date to last dose date of BIC + F/TAF or B/F/TAF (maximum duration: 193.4 weeks) plus 30 days
Adverse Event Reporting Description The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
 
Arm/Group Title BIC + F/TAF (Double-Blind Randomized) DTG + F/TAF (Double Blind Randomized): BIC + F/TAF to B/F/TAF (Open-Label Phase) DTG + F/TAF to B/F/TAF (Open-Label Phase)
Hide Arm/Group Description Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to BIC + F/TAF. Participants received BIC (75 mg) + F/TAF (200/25 mg) FDC + DTG placebo tablets orally once daily for 48 weeks. Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to DTG + FTC/TAF. Participants received DTG (50 mg) + F/TAF (200/25 mg) FDC + BIC placebo tablets orally once daily. Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Extension Phase from the BIC + F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet. Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Extension Phase from the DTG + F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet.
All-Cause Mortality
BIC + F/TAF (Double-Blind Randomized) DTG + F/TAF (Double Blind Randomized): BIC + F/TAF to B/F/TAF (Open-Label Phase) DTG + F/TAF to B/F/TAF (Open-Label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/33 (0.00%)   0/62 (0.00%)   0/30 (0.00%) 
Hide Serious Adverse Events
BIC + F/TAF (Double-Blind Randomized) DTG + F/TAF (Double Blind Randomized): BIC + F/TAF to B/F/TAF (Open-Label Phase) DTG + F/TAF to B/F/TAF (Open-Label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/65 (6.15%)   0/33 (0.00%)   3/62 (4.84%)   5/30 (16.67%) 
Gastrointestinal disorders         
Abdominal pain  1  0/65 (0.00%)  0/33 (0.00%)  0/62 (0.00%)  1/30 (3.33%) 
Colitis  1  0/65 (0.00%)  0/33 (0.00%)  0/62 (0.00%)  1/30 (3.33%) 
Umbilical hernia  1  1/65 (1.54%)  0/33 (0.00%)  0/62 (0.00%)  0/30 (0.00%) 
Infections and infestations         
Appendicitis  1  1/65 (1.54%)  0/33 (0.00%)  0/62 (0.00%)  0/30 (0.00%) 
Pyelonephritis  1  0/65 (0.00%)  0/33 (0.00%)  1/62 (1.61%)  0/30 (0.00%) 
Injury, poisoning and procedural complications         
Rib fracture  1  0/65 (0.00%)  0/33 (0.00%)  1/62 (1.61%)  0/30 (0.00%) 
Metabolism and nutrition disorders         
Diabetic ketoacidosis  1  1/65 (1.54%)  0/33 (0.00%)  0/62 (0.00%)  1/30 (3.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anal cancer  1  0/65 (0.00%)  0/33 (0.00%)  1/62 (1.61%)  0/30 (0.00%) 
Psychiatric disorders         
Psychotic disorder  1  1/65 (1.54%)  0/33 (0.00%)  0/62 (0.00%)  0/30 (0.00%) 
Substance-induced psychotic disorder  1  0/65 (0.00%)  0/33 (0.00%)  0/62 (0.00%)  1/30 (3.33%) 
Suicidal ideation  1  1/65 (1.54%)  0/33 (0.00%)  0/62 (0.00%)  0/30 (0.00%) 
Suicide attempt  1  0/65 (0.00%)  0/33 (0.00%)  0/62 (0.00%)  1/30 (3.33%) 
Renal and urinary disorders         
Bladder mass  1  0/65 (0.00%)  0/33 (0.00%)  0/62 (0.00%)  1/30 (3.33%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BIC + F/TAF (Double-Blind Randomized) DTG + F/TAF (Double Blind Randomized): BIC + F/TAF to B/F/TAF (Open-Label Phase) DTG + F/TAF to B/F/TAF (Open-Label Phase)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/65 (67.69%)   18/33 (54.55%)   42/62 (67.74%)   23/30 (76.67%) 
Gastrointestinal disorders         
Anal fissure  1  1/65 (1.54%)  2/33 (6.06%)  0/62 (0.00%)  0/30 (0.00%) 
Diarrhoea  1  9/65 (13.85%)  4/33 (12.12%)  4/62 (6.45%)  4/30 (13.33%) 
Flatulence  1  1/65 (1.54%)  2/33 (6.06%)  0/62 (0.00%)  0/30 (0.00%) 
Haemorrhoids  1  0/65 (0.00%)  2/33 (6.06%)  2/62 (3.23%)  0/30 (0.00%) 
Nausea  1  5/65 (7.69%)  3/33 (9.09%)  2/62 (3.23%)  3/30 (10.00%) 
General disorders         
Chest pain  1  0/65 (0.00%)  2/33 (6.06%)  0/62 (0.00%)  0/30 (0.00%) 
Fatigue  1  4/65 (6.15%)  2/33 (6.06%)  3/62 (4.84%)  0/30 (0.00%) 
Pain  1  0/65 (0.00%)  2/33 (6.06%)  0/62 (0.00%)  0/30 (0.00%) 
Infections and infestations         
Bronchitis  1  2/65 (3.08%)  0/33 (0.00%)  2/62 (3.23%)  3/30 (10.00%) 
Chlamydial infection  1  4/65 (6.15%)  2/33 (6.06%)  4/62 (6.45%)  1/30 (3.33%) 
Conjunctivitis  1  0/65 (0.00%)  0/33 (0.00%)  1/62 (1.61%)  2/30 (6.67%) 
Furuncle  1  3/65 (4.62%)  2/33 (6.06%)  4/62 (6.45%)  2/30 (6.67%) 
Gastroenteritis  1  1/65 (1.54%)  2/33 (6.06%)  1/62 (1.61%)  2/30 (6.67%) 
Gonorrhoea  1  3/65 (4.62%)  1/33 (3.03%)  5/62 (8.06%)  2/30 (6.67%) 
Influenza  1  1/65 (1.54%)  1/33 (3.03%)  4/62 (6.45%)  2/30 (6.67%) 
Nasopharyngitis  1  3/65 (4.62%)  1/33 (3.03%)  3/62 (4.84%)  3/30 (10.00%) 
Pharyngitis  1  2/65 (3.08%)  1/33 (3.03%)  3/62 (4.84%)  2/30 (6.67%) 
Proctitis gonococcal  1  1/65 (1.54%)  1/33 (3.03%)  2/62 (3.23%)  5/30 (16.67%) 
Sinusitis  1  3/65 (4.62%)  0/33 (0.00%)  4/62 (6.45%)  2/30 (6.67%) 
Syphilis  1  3/65 (4.62%)  1/33 (3.03%)  8/62 (12.90%)  5/30 (16.67%) 
Upper respiratory tract infection  1  7/65 (10.77%)  1/33 (3.03%)  4/62 (6.45%)  1/30 (3.33%) 
Urethritis  1  3/65 (4.62%)  3/33 (9.09%)  1/62 (1.61%)  1/30 (3.33%) 
Urinary tract infection  1  0/65 (0.00%)  1/33 (3.03%)  0/62 (0.00%)  2/30 (6.67%) 
Viral infection  1  0/65 (0.00%)  2/33 (6.06%)  2/62 (3.23%)  0/30 (0.00%) 
Injury, poisoning and procedural complications         
Exposure to communicable disease  1  2/65 (3.08%)  2/33 (6.06%)  6/62 (9.68%)  2/30 (6.67%) 
Muscle strain  1  1/65 (1.54%)  1/33 (3.03%)  5/62 (8.06%)  1/30 (3.33%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  4/65 (6.15%)  2/33 (6.06%)  3/62 (4.84%)  0/30 (0.00%) 
Back pain  1  4/65 (6.15%)  0/33 (0.00%)  5/62 (8.06%)  1/30 (3.33%) 
Costochondritis  1  0/65 (0.00%)  2/33 (6.06%)  0/62 (0.00%)  0/30 (0.00%) 
Osteoarthritis  1  0/65 (0.00%)  0/33 (0.00%)  0/62 (0.00%)  2/30 (6.67%) 
Nervous system disorders         
Headache  1  6/65 (9.23%)  1/33 (3.03%)  0/62 (0.00%)  1/30 (3.33%) 
Psychiatric disorders         
Anxiety  1  1/65 (1.54%)  2/33 (6.06%)  0/62 (0.00%)  1/30 (3.33%) 
Stress  1  0/65 (0.00%)  2/33 (6.06%)  0/62 (0.00%)  0/30 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/65 (4.62%)  1/33 (3.03%)  7/62 (11.29%)  0/30 (0.00%) 
Oropharyngeal pain  1  1/65 (1.54%)  1/33 (3.03%)  4/62 (6.45%)  1/30 (3.33%) 
Rhinitis allergic  1  1/65 (1.54%)  2/33 (6.06%)  0/62 (0.00%)  1/30 (3.33%) 
Skin and subcutaneous tissue disorders         
Dermatitis  1  2/65 (3.08%)  0/33 (0.00%)  0/62 (0.00%)  2/30 (6.67%) 
Pruritus  1  0/65 (0.00%)  2/33 (6.06%)  0/62 (0.00%)  1/30 (3.33%) 
Vascular disorders         
Hypertension  1  1/65 (1.54%)  1/33 (3.03%)  1/62 (1.61%)  2/30 (6.67%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02397694    
Other Study ID Numbers: GS-US-141-1475
First Submitted: March 20, 2015
First Posted: March 25, 2015
Results First Submitted: February 27, 2018
Results First Posted: March 27, 2018
Last Update Posted: April 7, 2020