Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Phase 3

Completed

Conditions: HIV-1 Infection

Interventions: Drug: B/F/TAF
Drug: ABC/DTG/3TC
Drug: ABC/DTG/3TC Placebo
Drug: B/F/TAF Placebo

Registration Number: NCT02607930

Lead Sponsor: Gilead Sciences

Brief Summary: The primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 631

Inclusion Criteria

Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
Adequate renal function: Estimated glomerular filtration rate ≥ 50 milliliter per minute (mL/min) (≥ 0.83 milliliter per second [mL/sec]) according to the Cockcroft-Gault formula
Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences

Key

Exclusion Criteria

An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to study protocol)
Decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)
Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
Females who are pregnant (as confirmed by positive serum pregnancy test)
Females who are breastfeeding
Chronic Hepatitis B Virus (HBV) infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B/F/TAF	B/F/TAF	B/F/TAF + ABC/DTG/3TC placebo administered without regard to food for at least 144 weeks.
B/F/TAF	ABC/DTG/3TC Placebo	B/F/TAF + ABC/DTG/3TC placebo administered without regard to food for at least 144 weeks.
ABC/DTG/3TC	ABC/DTG/3TC	ABC/DTG/3TC + B/F/TAF placebo administered without regard to food for at least 144 weeks.
ABC/DTG/3TC	B/F/TAF Placebo	ABC/DTG/3TC + B/F/TAF placebo administered without regard to food for at least 144 weeks.
Open-label Phase B/F/TAF to B/F/TAF	B/F/TAF	After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.
Open-label Phase ABC/DTG/3TC to B/F/TAF	B/F/TAF	After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm	Week 96	The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 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 Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm	Week 144	The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 144 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 Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm	Week 48	The percentage of participants achieving HIV-1 RNA \< 20 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.
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm	Week 96	The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 96 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 Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm	Week 144	The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 144 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.
Change From Baseline in log10 HIV-1 RNA at Week 48	Baseline, Week 48
Change From Baseline in log10 HIV-1 RNA at Week 96	Baseline, Week 96
Change From Baseline in log10 HIV-1 RNA at Week 144	Baseline, Week 144
Change From Baseline in CD4+ Cell Count at Week 48	Baseline, Week 48
Change From Baseline in CD4+ Cell Count at Week 96	Baseline, Week 96
Change From Baseline in CD4+ Cell Count at Week 144	Baseline, Week 144
Percentage Change From Baseline in Hip BMD at Week 48	Baseline, Week 48
Percentage Change From Baseline in Hip BMD at Week 96	Baseline, Week 96
Percentage Change From Baseline in Hip BMD at Week 144	Baseline, Week 144
Percentage Change From Baseline in Spine BMD at Week 48	Baseline, Week 48
Percentage Change From Baseline in Spine BMD at Week 96	Baseline, Week 96
Percentage Change From Baseline in Spine BMD at Week 144	Baseline, Week 144
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm	Baseline, open-label Week 48	The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm	Baseline, open-label Week 48	The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm	Baseline, open-label Week 96	The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with non-missing HIV-1 RNA value at that visit.
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm	Baseline, open-label Week 96	The percentage of participants with HIV-1 RNA \< 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
Change From Baseline in CD4+ Cell Count at Week 48 Open-Label	Baseline, open-label Week 48
Change From Baseline in CD4+ Cell Count at Week 96 Open-Label	Baseline, open-label Week 96

Trial Locations

Locations (114): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Spectrum Medical Group
🇺🇸
Phoenix, Arizona, United States
Pueblo Family Physicians
🇺🇸
Phoenix, Arizona, United States
Kaiser Permanente Medical Center
🇺🇸
Los Angeles, California, United States
Ruane Clinical Research Group, Inc.
🇺🇸
Los Angeles, California, United States
Anthony Martin Mills MD A Medical Corporation, DBA Mills Clinical Research
🇺🇸
Los Angeles, California, United States
Alameda Health System- Highland Hospital
🇺🇸
Oakland, California, United States
University of California Davis
🇺🇸
Sacramento, California, United States
Kaiser Permanente Medical Group
🇺🇸
Sacramento, California, United States
La Playa Medical Group
🇺🇸
San Diego, California, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States