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

February 10, 2022 updated by: Gilead Sciences

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

657

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010 NSW
    • Victoria
      • Carlton, Victoria, Australia, 3053
      • Clayton, Victoria, Australia, 3168
      • Melbourne, Victoria, Australia, 3004
      • Prahran, Victoria, Australia, 3181
        • Prahran Market Clinic
      • Prahran, Victoria, Australia, 3068
  • Belgium
      • Antwerp, Belgium, 2000
      • Ghent, Belgium, B-9000
  • Canada
      • Montreal, Canada, H4A 3J1
        • McGill University Health Center
      • Ottawa, Canada, K1H 8L6
      • Toronto, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Canada, M5G 1K2
      • Toronto, Canada, M5G2N2
      • Winnipeg, Canada, R3A 1R9
  • Dominican Republic
      • Santo Domingo, Dominican Republic, 10103
  • France
      • Montpellier, France, 34295
      • Nice, France, 06200
        • CHU de Nice Archet I
      • Tourcoing, France, 59200
      • Tourcoing, France, 59208
  • Germany
      • Berlin, Germany, 12157
      • Düsseldorf, Germany, 40237
      • Essen, Germany, 45122
      • Frankfurt, Germany, 60590
      • Frankfurt, Germany, 60311
      • Hamburg, Germany, 20146
      • Köln, Germany, 50924
        • Uniklinik Köln
      • München, Germany, 80335
  • Italy
      • Bergamo, Italy, 24127
      • Milano, Italy, 20127
      • Roma, Italy
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
      • San Juan, Puerto Rico, 00909-1711
  • Spain
      • Alicante, Spain, 3010
      • Badalona, Spain, 08907
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28034
      • Madrid, Spain, 28007
      • Malaga, Spain, 29010
      • Vigo, Spain, 36312
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
      • Birmingham, United Kingdom, B4 6DH
      • London, United Kingdom, NW3 2QG
      • London, United Kingdom, SW17 0QT
        • St George's Healthcare NHS Trust
      • London, United Kingdom, SE5 9RJ
      • London, United Kingdom, WC1E 6JB
      • London, United Kingdom, E1 1BB.
      • London, United Kingdom, SE19 3ST
      • London, United Kingdom, SW10 9NH
        • Chelsea and Westminster NHS Trust
      • Manchester, United Kingdom, M8 5RB
      • Manchester, United Kingdom, M13 0FH
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
      • Phoenix, Arizona, United States, 85025
    • California
      • Beverly Hills, California, United States, 90211
      • Los Angeles, California, United States, 90027
      • Los Angeles, California, United States, 90036
      • Los Angeles, California, United States, 90069
      • Los Angeles, California, United States, 90059
      • Sacramento, California, United States, 95817
      • Sacramento, California, United States, 95825
      • San Francisco, California, United States, 94102
        • Optimus Medical - ClinEdge - PPDS
      • San Leandro, California, United States, 94577
        • Kaiser Permanente
    • Colorado
      • Denver, Colorado, United States, 80205
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
      • Washington, District of Columbia, United States, 20037
      • Washington, District of Columbia, United States, 20036
    • Florida
      • DeLand, Florida, United States, 32720
      • Fort Lauderdale, Florida, United States, 33316
      • Fort Pierce, Florida, United States, 34982
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33133
      • Miami Beach, Florida, United States, 33139
      • Oakland Park, Florida, United States, 33306
      • Orlando, Florida, United States, 32803
      • Pensacola, Florida, United States, 32504
      • Tampa, Florida, United States, 33614
      • West Palm Beach, Florida, United States, 33407
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Atlanta, Georgia, United States, 30312
      • Decatur, Georgia, United States, 30033
      • Macon, Georgia, United States, 31201
      • Savannah, Georgia, United States, 31405
    • Illinois
      • Chicago, Illinois, United States, 60613
      • Chicago, Illinois, United States, 60657
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02129
      • Springfield, Massachusetts, United States, 01105
    • Michigan
      • Berkley, Michigan, United States, 48072
      • Detroit, Michigan, United States, 48202
    • Missouri
      • Kansas City, Missouri, United States, 64111
      • Saint Louis, Missouri, United States, 63139
      • Saint Louis, Missouri, United States, 63108
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
      • Newark, New Jersey, United States, 07102
    • New York
      • Albany, New York, United States, 12208
      • Bronx, New York, United States, 10461
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10011
      • New York, New York, United States, 10011-4121
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
      • Charlotte, North Carolina, United States, 28207
      • Greensboro, North Carolina, United States, 27401
        • Cone Health Regional Center for Infectious Disease
      • Greenville, North Carolina, United States, 27858-4354
      • Huntersville, North Carolina, United States, 28078
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cincinnati, Ohio, United States, 45267
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Health Network
    • South Carolina
      • Columbia, South Carolina, United States, 29203-6840
    • Texas
      • Austin, Texas, United States, 78705
      • Bellaire, Texas, United States, 77401
      • Dallas, Texas, United States, 75235
      • Dallas, Texas, United States, 75202
      • Dallas, Texas, United States, 75215
        • AIDS Arms Inc
      • Dallas, Texas, United States, 75246
        • North Texas Infectious Diseases Consultants PA
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77004
      • Houston, Texas, United States, 77098
      • Longview, Texas, United States, 75605
    • Virginia
      • Annandale, Virginia, United States, 22003-7313
    • Washington
      • Seattle, Washington, United States, 98104
      • Spokane, Washington, United States, 99204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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 ≥ 30 mL per minute (min) (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula

Key Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: B/F/TAF
B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks.
Drug: B/F/TAF
50/200/25 milligrams (mg) FDC tablets administered orally, once daily
Other Names:
  • Biktarvy®
  • GS-9883/F/TAF
Drug: DTG Placebo
Tablets administered orally, once daily
Drug: F/TAF Placebo
Tablets administered orally, once daily
Active Comparator: DTG + F/TAF
DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks.
Drug: DTG
50 mg tablets administered orally, once daily
Other Names:
  • Tivicay®
Drug: F/TAF
200/25 mg tablets administered orally, once daily
Other Names:
  • Descovy®
Drug: B/F/TAF Placebo
Tablets administered orally, once daily
Experimental: Open-label Phase B/F/TAF from 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.
Drug: B/F/TAF
50/200/25 milligrams (mg) FDC tablets administered orally, once daily
Other Names:
  • Biktarvy®
  • GS-9883/F/TAF
Experimental: Open-label Phase B/F/TAF from DTG + 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.
Drug: B/F/TAF
50/200/25 milligrams (mg) FDC tablets administered orally, once daily
Other Names:
  • Biktarvy®
  • GS-9883/F/TAF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Time Frame: 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.
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in CD4+ Cell Count at Week 48
Time Frame: Baseline, Week 48
Baseline, Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Time Frame: 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.
Week 96
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
Time Frame: 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.
Week 144
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
Time Frame: 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.
Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Time Frame: 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.
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
Time Frame: 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.
Week 144
Change From Baseline in log10 HIV-1 RNA at Week 48
Time Frame: Baseline, Week 48
Baseline, Week 48
Change From Baseline in log10 HIV-1 RNA at Week 96
Time Frame: Baseline, Week 96
Baseline, Week 96
Change From Baseline in log10 HIV-1 RNA at Week 144
Time Frame: Baseline, Week 144
Baseline, Week 144
Change From Baseline in CD4+ Cell Count at Week 96
Time Frame: Baseline, Week 96
Baseline, Week 96
Change From Baseline in CD4+ Cell Count at Week 144
Time Frame: Baseline, 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
Time Frame: 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.
Baseline, open-label Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm
Time Frame: 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.
Baseline, open-label Week 48
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm
Time Frame: 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.
Baseline, open-label Week 96
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm
Time Frame: 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.
Baseline, open-label Week 96
Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
Time Frame: Baseline, open-label Week 48
Baseline, open-label Week 48
Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
Time Frame: Baseline, open-label Week 96
Baseline, open-label Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2015

Primary Completion (Actual)

May 12, 2017

Study Completion (Actual)

July 5, 2021

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-380-1490
  • 2015-003988-10 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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