Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
- Conditions
- HIV-1 Infection
- Interventions
- Registration Number
- NCT02607956
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This 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 dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 657
- 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 ≥ 30 mL per minute (min) (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula
Key
- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
- Decompensated cirrhosis (eg, 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
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 + DTG + F/TAF placebo administered without regard to food for at least 144 weeks. B/F/TAF DTG Placebo B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks. B/F/TAF F/TAF Placebo B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks. DTG + F/TAF F/TAF DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks. DTG + F/TAF B/F/TAF Placebo DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks. Open-label Phase B/F/TAF from 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 B/F/TAF from DTG + 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. DTG + F/TAF DTG DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks.
- 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 < 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.
Change From Baseline in log10 HIV-1 RNA at Week 96 Baseline, Week 96 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 144 Baseline, Week 144 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 < 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.
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 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 for the all B/F/TAF analysis. 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 nonmissing 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 for the all B/F/TAF analysis. 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 for the all B/F/TAF analysis. 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 nonmissing 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 for the all B/F/TAF analysis. 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 (15)
St George's Healthcare NHS Trust
🇬🇧London, United Kingdom
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Canada
Prahran Market Clinic
🇦🇺Prahran, Victoria, Australia
Chelsea and Westminster NHS Trust
🇬🇧London, United Kingdom
McGill University Health Center
🇨🇦Montreal, Canada
CHU de Nice Archet I
🇫🇷Nice, France
Uniklinik Köln
🇩🇪Köln, Germany
Optimus Medical - ClinEdge - PPDS
🇺🇸San Francisco, California, United States
Kaiser Permanente
🇺🇸San Leandro, California, United States
Cone Health Regional Center for Infectious Disease
🇺🇸Greensboro, North Carolina, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
AIDS Arms Inc
🇺🇸Dallas, Texas, United States
North Texas Infectious Diseases Consultants PA
🇺🇸Dallas, Texas, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain