Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

October 22, 2020 updated by: Gilead Sciences

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
567

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Sydney, New South Wales, Australia, 2010
  • Belgium
      • Ghent, Belgium, 9000
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2T1
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
      • Montreal, Quebec, Canada, H2l 4P9
      • Montreal, Quebec, Canada, H3A 1T1
  • France
      • NICE Cedex 03, France, 6202
      • Nantes, France, 44093
      • Paris, France, 75010
      • Paris cedex 20, France, 75970
  • Germany
      • Berlin, Germany, 13353
      • Berlin, Germany, 12157
      • Bonn, Germany, 53127
      • Essen, Germany, 45122
      • Frankfurt am Main, Germany, 60596
      • Hamburg, Germany, 20146
      • Munich, Germany, 80336
      • München, Germany, 80335
  • Italy
      • Roma, Italy, 00149
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
      • San Juan, Puerto Rico, 00909-1711
  • Spain
      • Badalona, Spain, 08916
      • Badalona, Spain, 8907
      • Barcelona, Spain, 8025
      • Cordoba, Spain, 14004
      • Madrid, Spain, 28034
      • Santiago de Compostela, Spain, 15706
      • Sevilla, Spain, 41013
  • United Kingdom
      • Brighton, United Kingdom, BN2 3EW
      • Manchester, United Kingdom, M8 5RB
      • Manchester, United Kingdom, M13 0FH
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
    • California
      • Beverly Hills, California, United States, 90211
      • Los Angeles, California, United States, 90027
      • Los Angeles, California, United States, 90036
      • Los Angeles, California, United States, 90033
      • Los Angeles, California, United States, 90069
      • Oakland, California, United States, 94609
      • Oakland, California, United States, 94602
      • Palm Springs, California, United States, 92264
      • Sacramento, California, United States, 95825
      • Sacramento, California, United States, 95187
      • San Leandro, California, United States, 94577
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
      • Washington, District of Columbia, United States, 20036
    • Florida
      • DeLand, Florida, United States, 32720
      • Fort Lauderdale, Florida, United States, 33308
      • Fort Lauderdale, Florida, United States, 33316
      • Fort Pierce, Florida, United States, 34982
      • Miami, Florida, United States, 33133
      • Miami Beach, Florida, United States, 33139
      • Orlando, Florida, United States, 32803
      • Pensacola, Florida, United States, 32504
      • Tampa, Florida, United States, 33614
      • Vero Beach, Florida, United States, 32960
      • West Palm Beach, Florida, United States, 33401
      • Wilton Manors, Florida, United States, 33305
    • Georgia
      • Augusta, Georgia, United States, 30912
      • Decatur, Georgia, United States, 30033
      • Macon, Georgia, United States, 31201
      • Savannah, Georgia, United States, 31401
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Illinois
      • Chicago, Illinois, United States, 60613
      • Chicago, Illinois, United States, 60657
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Massachusetts
      • Boston, Massachusetts, United States, 02118-2393
      • Springfield, Massachusetts, United States, 01105
    • Michigan
      • Berkley, Michigan, United States, 48072
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
    • Missouri
      • Kansas City, Missouri, United States, 64111
      • Saint Louis, Missouri, United States, 63139
    • New Jersey
      • Newark, New Jersey, United States, 07102
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
    • New York
      • Bronx, New York, United States, 10467-2490
      • Buffalo, New York, United States, 14215
      • New York, New York, United States, 10011
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
      • Greenville, North Carolina, United States, 27834
      • Huntersville, North Carolina, United States, 28078
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0560
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • South Carolina
      • Columbia, South Carolina, United States, 29203-6840
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75246
      • Dallas, Texas, United States, 75219
      • Houston, Texas, United States, 77004
      • Houston, Texas, United States, 77098
      • Longview, Texas, United States, 75605
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).
  • Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit.
  • HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit.
  • Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
  • Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC.

Key Exclusion Criteria:

  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance.
  • Active tuberculosis infection.
  • Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
  • Females who are pregnant.
  • Females who are breastfeeding.
  • Acute hepatitis in the 30 days prior to study entry.
  • Chronic Hepatitis B Virus (HBV) infection.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Blinded Phase: B/F/TAF
B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks
Drug: B/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food
Other Names:
  • Bictegravir (previously referred to as GS-9883)/Emtricitabine/Tenofovir Alafenamide
  • Biktarvy® [BVY]
Drug: ABC/DTG/3TC Placebo
Tablets administered orally once daily without regard to food
Active Comparator: Blinded Phase: ABC/DTG/3TC
ABC/DTG/3TC + B/F/TAF placebo for at least 48 weeks
Drug: ABC/DTG/3TC
600/50/300 mg FDC tablets administered orally once daily without regard to food
Other Names:
  • Triumeq®
Drug: B/F/TAF Placebo
Tablets administered orally once daily without regard to food
Experimental: Open-Label Phase
At the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF is demonstrated following review of unblinded data, participants in a country where B/F/TAF FDC is not available will be given the option to receive B/F/TAF FDC in an open-label extension phase for up to 96 weeks, or until the product becomes accessible to subjects through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.
Drug: B/F/TAF
50/200/25 mg FDC tablets administered orally once daily without regard to food
Other Names:
  • Bictegravir (previously referred to as GS-9883)/Emtricitabine/Tenofovir Alafenamide
  • Biktarvy® [BVY]

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 With HIV-1 RNA < 50 Copies/mL 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
Spine Bone Mineral Density (BMD) at Baseline
Time Frame: Baseline
Baseline
Percentage Change From Baseline in Spine BMD at Week 48
Time Frame: Baseline; Week 48
Baseline; Week 48
Hip Bone Mineral Density at Baseline
Time Frame: Baseline
Baseline
Percentage Change From Baseline in Hip BMD at Week 48
Time Frame: Baseline; Week 48
Baseline; Week 48

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 9, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-380-1844
  • 2015-004025-14 (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
  • Statistical Analysis Plan (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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