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
- Conditions
- HIV-1 Infection
- Interventions
- Drug: B/F/TAFDrug: ABC/DTG/3TCDrug: ABC/DTG/3TC PlaceboDrug: 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
- 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
- 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 Spine BMD at Week 48 Baseline, Week 48 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 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)
Infectious Disease Specialists of Atlanta
🇺🇸Decatur, Georgia, United States
Prime healthcare services - St Michael's LLC d/b/a Saint Michael's medical center
🇺🇸Newark, New Jersey, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Be Well Medical Center
🇺🇸Berkley, Michigan, United States
Upstate Infectious Disease Associates
🇺🇸Albany, New York, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
AIDS Arms Inc
🇺🇸Dallas, Texas, United States
MetroHealth Research Institute
🇺🇸Cleveland, Ohio, United States
Research Access Network
🇺🇸Houston, Texas, United States
Peter Shalit MD
🇺🇸Seattle, Washington, United States
La Playa Medical Group
🇺🇸San Diego, California, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Providence Hospital - DC
🇺🇸Washington, District of Columbia, United States
Capital Medical Associates
🇺🇸Washington, District of Columbia, United States
Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States
Pueblo Family Physicians
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Apex Research
🇺🇸Denver, Colorado, United States
The Medical College of Wisconsin, Inc.
🇺🇸Milwaukee, Wisconsin, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Canada
St. Joseph's Comprehensive Research Institute
🇺🇸Tampa, Florida, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, 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
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Alameda Health System- Highland Hospital
🇺🇸Oakland, California, United States
Kaiser Permanente
🇺🇸San Leandro, California, United States
Whitman-Walker Institute
🇺🇸Washington, District of Columbia, United States
Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Therafirst Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Gary J. Richmond, M.D., P.A.
🇺🇸Fort Lauderdale, Florida, United States
AHF Kinder Medical Group
🇺🇸Miami, Florida, United States
Midway Immunology and Research Center
🇺🇸Fort Pierce, Florida, United States
AIDS Healthcare Foundation-Miami Beach
🇺🇸Pensacola, Florida, United States
AIDS Research and Treatment Center of the Treasure Coast
🇺🇸Vero Beach, Florida, United States
Triple O Research Institute PA
🇺🇸West Palm Beach, Florida, United States
Atlanta Infectious Disease Group PC
🇺🇸Atlanta, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Aids Research Consortium of Atlanta Inc
🇺🇸Chapel Hill, North Carolina, United States
Chatham County Health Department
🇺🇸Savannah, Georgia, United States
Indiana CTSI Clinical Research Center
🇺🇸Indianapolis, Indiana, United States
Louisiana State University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Kansas City CARE Clinic
🇺🇸Kansas City, Missouri, United States
Southampton Clinical Research Group, Inc.
🇺🇸Saint Louis, Missouri, United States
Southampton Healthcare Inc
🇺🇸Saint Louis, Missouri, United States
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
Bronx Care
🇺🇸Bronx, New York, United States
North Shore University Hospital-(Manhasset)
🇺🇸Manhasset, New York, United States
Evergreen Health
🇺🇸Buffalo, New York, United States
ID Consultants PA
🇺🇸Charlotte, North Carolina, United States
Rosedale Infectious Diseases
🇺🇸Huntersville, North Carolina, United States
Kings College Hospital
🇬🇧London, United Kingdom
Summa Health System
🇺🇸Akron, Ohio, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Saint Hope Foundation Inc
🇺🇸Bellaire, Texas, United States
UT Southwestern Clinical Trials Office
🇺🇸Dallas, Texas, United States
North Texas Infectious Diseases Consultants PA
🇺🇸Dallas, Texas, United States
Therapeutic Concepts
🇺🇸Houston, Texas, United States
Gordon E Crofoot MD PA
🇺🇸Houston, Texas, United States
Diagnostic Clinic of Longview Center For Clinical Research (DCOL)
🇺🇸Longview, Texas, United States
Multicare Rockwood HIV Critical Care Clinic
🇺🇸Spokane, Washington, United States
UZ Gent
🇧🇪Ghent, Belgium
Clinique Medicale L'actuel
🇨🇦Montreal, Canada
Clinique OPUS Inc
🇨🇦Montreal, Canada
McGill University Health Center
🇨🇦Montreal, Canada
Ottawa Hospital
🇨🇦Ottawa, Canada
Maple Leaf Research
🇨🇦Toronto, Canada
Spectrum Health Care
🇨🇦Vancouver, Canada
Instituto Dominicano de Estudios Virologicos IDEV
🇩🇴Santo Domingo, Dominican Republic
Hôpital Saint Louis
🇫🇷PARIS cedex 10, France
Winnipeg Regional Health Authority
🇨🇦Winnipeg, Canada
CHU de Nice Archet I
🇫🇷Nice, France
Hôpital de La Croix Rousse
🇫🇷Lyon cedex 04, France
Hôpital Saint Antoine
🇫🇷Paris, France
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
🇩🇪Berlin, Germany
Groupe Hospitalier Bichat Claude Bernard
🇫🇷Tourcoing, France
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
ICH Study Center
🇩🇪Hamburg, Germany
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Ospedale San Raffaele S.r.l. - PPDS
🇮🇹Milano, Italy
Hope Clinical Research
🇵🇷San Juan, Puerto Rico
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
🇮🇹Roma, Italy
University of Puerto Rico
🇵🇷San Juan, Puerto Rico
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario de Bellvitge
🇪🇸Badalona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
C.H. Regional Reina Sofia - PPDS
🇪🇸Cordoba, Spain
Hospital Universitario La Paz - PPDS
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
CHUVI - H.U. Alvaro Cunqueiro
🇪🇸Vigo, Spain
Brighton and Sussex University Hospitals NHS Trust
🇬🇧Brighton, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre
🇬🇧London, United Kingdom
Chelsea and Westminster NHS Trust
🇬🇧London, United Kingdom
Mortimer Market Centre
🇬🇧London, United Kingdom
North Manchester General Hospital - PPDS
🇬🇧Manchester, United Kingdom
Medical University of South Carolina PPDS
🇺🇸Columbia, South Carolina, United States
University of California Davis
🇺🇸Sacramento, California, United States
Kaiser Permanente Medical Group
🇺🇸Sacramento, California, United States
Wake Forest Baptist Medical Center - PPDS
🇺🇸Winston-Salem, North Carolina, United States
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
Montefiore Medical Center
🇺🇸Bronx, New York, United States