HIV-1 Infection
Conditions
Keywords
Adult, HIV, naive
Brief summary
This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.
Interventions
DRUGBIC
75 mg tablet administered orally once daily
DRUGF/TAF
200/25 mg FDC tablet administered orally once daily
DRUGDTG
50 mg tablet administered orally once daily
DRUGBIC Placebo
Tablet administered orally once daily
DRUGDTG Placebo
Tablet administered orally once daily
DRUGB/F/TAF
50/200/25 mg FDC tablet administered orally once daily
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent) * Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening * Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC) * Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula * CD4+ cell count ≥ 200 cells/µL at screening Key
Exclusion criteria
* A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol * Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP) * Chronic hepatitis B virus (HBV) infection * Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible) * Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline * Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm. | Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State | 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8 | Tmax was defined as the time to Cmax. |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48 | Week 48 | 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. |
| The Change From Baseline in log10 HIV-1 RNA at Week 12 | Baseline; Week 12 | — |
| The Change From Baseline in log10 HIV-1 RNA at Week 24 | Baseline; Week 24 | — |
| The Change From Baseline in log10 HIV-1 RNA at Week 48 | Baseline; Week 48 | — |
| The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12 | Baseline; Week 12 | — |
| The Change From Baseline in CD4+ Cell Count at Week 24 | Baseline; Week 24 | — |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12 | Week 12 | 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. |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase | First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase) | — |
| Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase | First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase) | — |
| PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State | 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8 | Cmax is the maximum observed plasma concentration of the drug. |
| PK Parameter:Ctau for BIC, FTC and TFV | 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8 | Ctau was defined as the observed drug concentration at the end of the dosing interval. |
| PK Parameter: AUCtau for BIC, FTC, TAF, and TFV | 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8 | AUCtau is defined as the area under the concentration-time curve of the drug over time. |
| PK Parameter: t1/2 of BIC, FTC, TAF, and TFV | 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8 | t1/2 was defined as the terminal elimination half-life of the drug |
| The Change From Baseline in CD4+ Cell Count at Week 48 | Baseline; Week 48 | — |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| BIC + F/TAF 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). | 65 |
| DTG + F/TAF 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). | 33 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-Blinded Phase | Adverse Event | 1 | 0 |
| Double-Blinded Phase | Lost to Follow-up | 1 | 1 |
| Double-Blinded Phase | Non-compliance with study drug | 0 | 2 |
| Double-Blinded Phase | Withdrawal by Subject | 1 | 0 |
| Open Label Extension Phase | Lost to Follow-up | 4 | 0 |
| Open Label Extension Phase | Protocol Violation | 1 | 0 |
| Open Label Extension Phase | Withdrew Consent | 3 | 1 |
Baseline characteristics
| Characteristic | Total | DTG + F/TAF | BIC + F/TAF |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 12.1 | 38 years STANDARD_DEVIATION 12.9 | 34 years STANDARD_DEVIATION 11.4 |
| CD4 Cell Count | 483 cells/μL STANDARD_DEVIATION 220.3 | 507 cells/μL STANDARD_DEVIATION 271 | 471 cells/μL STANDARD_DEVIATION 190.9 |
| CD4 Cell Count Category < 200 cells/μL | 6 Participants | 3 Participants | 3 Participants |
| CD4 Cell Count Category ≥ 200 to < 350 cells/µL | 25 Participants | 8 Participants | 17 Participants |
| CD4 Cell Count Category ≥ 350 to < 500 cells/µL | 26 Participants | 6 Participants | 20 Participants |
| CD4 Cell Count Category ≥ 500 cells/µL | 41 Participants | 16 Participants | 25 Participants |
| HIV-1 RNA | 4.39 log10 copies/mL STANDARD_DEVIATION 0.795 | 4.38 log10 copies/mL STANDARD_DEVIATION 0.866 | 4.39 log10 copies/mL STANDARD_DEVIATION 0.764 |
| HIV-1 RNA category ≤ 100,000 copies/mL | 81 Participants | 26 Participants | 55 Participants |
| HIV-1 RNA category > 100,000 to ≤ 400,000 copies/mL | 12 Participants | 6 Participants | 6 Participants |
| HIV-1 RNA category > 400,000 copies/mL | 5 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 36 Participants | 12 Participants | 24 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 15 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 83 Participants | 29 Participants | 54 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 56 Participants | 18 Participants | 38 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 94 Participants | 30 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 33 | 0 / 62 | 0 / 30 |
| other Total, other adverse events | 44 / 65 | 18 / 33 | 42 / 62 | 23 / 30 |
| serious Total, serious adverse events | 4 / 65 | 0 / 33 | 3 / 62 | 5 / 30 |
Outcome results
Primary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| BIC + F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm. | 96.9 percentage of participants |
| DTG + F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm. | 93.9 percentage of participants |
p-value: 0.595% CI: [-8.5, 14.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12
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
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIC + F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12 | 93.8 percentage of participants |
| DTG + F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12 | 93.9 percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48
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
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIC + F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48 | 96.9 percentage of participants |
| DTG + F/TAF | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48 | 90.9 percentage of participants |
Secondary
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase
Time frame: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)
Population: Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIC + F/TAF | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase | 87.7 percentage of participants |
| DTG + F/TAF | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase | 72.7 percentage of participants |
Secondary
Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase
Time frame: First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIC + F/TAF | Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase | 87.5 percentage of participants |
| DTG + F/TAF | Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase | 87.5 percentage of participants |
Secondary
PK Parameter: AUCtau for BIC, FTC, TAF, and TFV
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
Population: Participants in the PK Substudy Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIC + F/TAF | PK Parameter: AUCtau for BIC, FTC, TAF, and TFV | BIC | 139778.8 h*ng/mL | Standard Deviation 37810.07 |
| BIC + F/TAF | PK Parameter: AUCtau for BIC, FTC, TAF, and TFV | FTC | 11605.4 h*ng/mL | Standard Deviation 3241.84 |
| BIC + F/TAF | PK Parameter: AUCtau for BIC, FTC, TAF, and TFV | TAF | 247.4 h*ng/mL | Standard Deviation 140.62 |
| BIC + F/TAF | PK Parameter: AUCtau for BIC, FTC, TAF, and TFV | TFV | 316.0 h*ng/mL | Standard Deviation 74.01 |
| DTG + F/TAF | PK Parameter: AUCtau for BIC, FTC, TAF, and TFV | TFV | 369.4 h*ng/mL | Standard Deviation 147.96 |
| DTG + F/TAF | PK Parameter: AUCtau for BIC, FTC, TAF, and TFV | BIC | NA h*ng/mL | — |
| DTG + F/TAF | PK Parameter: AUCtau for BIC, FTC, TAF, and TFV | TAF | 245.6 h*ng/mL | Standard Deviation 125.03 |
| DTG + F/TAF | PK Parameter: AUCtau for BIC, FTC, TAF, and TFV | FTC | 14689.8 h*ng/mL | Standard Deviation 5869.37 |
Secondary
PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIC + F/TAF | PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State | BIC | 9344.3 ng/mL | Standard Deviation 2506.33 |
| BIC + F/TAF | PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State | FTC | 1919.1 ng/mL | Standard Deviation 470.18 |
| BIC + F/TAF | PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State | TAF | 249.1 ng/mL | Standard Deviation 137.4 |
| BIC + F/TAF | PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State | TFV | 19.1 ng/mL | Standard Deviation 4.5 |
| DTG + F/TAF | PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State | TFV | 20.9 ng/mL | Standard Deviation 8.16 |
| DTG + F/TAF | PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State | BIC | NA ng/mL | — |
| DTG + F/TAF | PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State | TAF | 260.8 ng/mL | Standard Deviation 212.44 |
| DTG + F/TAF | PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State | FTC | 2157.1 ng/mL | Standard Deviation 486.44 |
Secondary
PK Parameter:Ctau for BIC, FTC and TFV
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
Population: Participants in the PK Substudy Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIC + F/TAF | PK Parameter:Ctau for BIC, FTC and TFV | BIC | 3508.6 ng/mL | Standard Deviation 1288.85 |
| BIC + F/TAF | PK Parameter:Ctau for BIC, FTC and TFV | FTC | 76.6 ng/mL | Standard Deviation 26.35 |
| BIC + F/TAF | PK Parameter:Ctau for BIC, FTC and TFV | TFV | 10.7 ng/mL | Standard Deviation 2.65 |
| DTG + F/TAF | PK Parameter:Ctau for BIC, FTC and TFV | BIC | NA ng/mL | — |
| DTG + F/TAF | PK Parameter:Ctau for BIC, FTC and TFV | FTC | 102.6 ng/mL | Standard Deviation 57.6 |
| DTG + F/TAF | PK Parameter:Ctau for BIC, FTC and TFV | TFV | 12.2 ng/mL | Standard Deviation 5.02 |
Secondary
PK Parameter: t1/2 of BIC, FTC, TAF, and TFV
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
Population: Participants in the PK Substudy Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| BIC + F/TAF | PK Parameter: t1/2 of BIC, FTC, TAF, and TFV | BIC | 16.73 hours |
| BIC + F/TAF | PK Parameter: t1/2 of BIC, FTC, TAF, and TFV | FTC | 5.46 hours |
| BIC + F/TAF | PK Parameter: t1/2 of BIC, FTC, TAF, and TFV | TAF | 0.37 hours |
| BIC + F/TAF | PK Parameter: t1/2 of BIC, FTC, TAF, and TFV | TFV | 37.74 hours |
| DTG + F/TAF | PK Parameter: t1/2 of BIC, FTC, TAF, and TFV | TFV | 34.47 hours |
| DTG + F/TAF | PK Parameter: t1/2 of BIC, FTC, TAF, and TFV | BIC | NA hours |
| DTG + F/TAF | PK Parameter: t1/2 of BIC, FTC, TAF, and TFV | TAF | 0.42 hours |
| DTG + F/TAF | PK Parameter: t1/2 of BIC, FTC, TAF, and TFV | FTC | 5.70 hours |
Secondary
PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State
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
Population: Participants in the PK Substudy Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| BIC + F/TAF | PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State | BIC | 2.00 hours |
| BIC + F/TAF | PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State | FTC | 1.50 hours |
| BIC + F/TAF | PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State | TAF | 1.00 hours |
| BIC + F/TAF | PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State | TFV | 1.50 hours |
| DTG + F/TAF | PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State | TFV | 2.00 hours |
| DTG + F/TAF | PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State | BIC | NA hours |
| DTG + F/TAF | PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State | TAF | 1.00 hours |
| DTG + F/TAF | PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State | FTC | 1.50 hours |
Secondary
The Change From Baseline in CD4+ Cell Count at Week 24
Time frame: Baseline; Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIC + F/TAF | The Change From Baseline in CD4+ Cell Count at Week 24 | 190 CD4 Cell Count (/μL) | Standard Deviation 176.8 |
| DTG + F/TAF | The Change From Baseline in CD4+ Cell Count at Week 24 | 155 CD4 Cell Count (/μL) | Standard Deviation 165.8 |
Secondary
The Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIC + F/TAF | The Change From Baseline in CD4+ Cell Count at Week 48 | 258 CD4 Cell Count (/μL) | Standard Deviation 221.7 |
| DTG + F/TAF | The Change From Baseline in CD4+ Cell Count at Week 48 | 188 CD4 Cell Count (/μL) | Standard Deviation 238.7 |
Secondary
The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12
Time frame: Baseline; Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIC + F/TAF | The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12 | 170 CD4 Cell Count (/μL) | Standard Deviation 150 |
| DTG + F/TAF | The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12 | 173 CD4 Cell Count (/μL) | Standard Deviation 220.5 |
Secondary
The Change From Baseline in log10 HIV-1 RNA at Week 12
Time frame: Baseline; Week 12
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIC + F/TAF | The Change From Baseline in log10 HIV-1 RNA at Week 12 | -3.03 log10 copies/mL | Standard Deviation 0.791 |
| DTG + F/TAF | The Change From Baseline in log10 HIV-1 RNA at Week 12 | -3.15 log10 copies/mL | Standard Deviation 0.731 |
Secondary
The Change From Baseline in log10 HIV-1 RNA at Week 24
Time frame: Baseline; Week 24
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIC + F/TAF | The Change From Baseline in log10 HIV-1 RNA at Week 24 | -3.09 log10 copies/mL | Standard Deviation 0.74 |
| DTG + F/TAF | The Change From Baseline in log10 HIV-1 RNA at Week 24 | -3.12 log10 copies/mL | Standard Deviation 0.757 |
Secondary
The Change From Baseline in log10 HIV-1 RNA at Week 48
Time frame: Baseline; Week 48
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIC + F/TAF | The Change From Baseline in log10 HIV-1 RNA at Week 48 | -3.09 log10 copies/mL | Standard Deviation 0.752 |
| DTG + F/TAF | The Change From Baseline in log10 HIV-1 RNA at Week 48 | -3.11 log10 copies/mL | Standard Deviation 0.852 |