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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02607956
Registration number
NCT02607956
Ethics application status
Date submitted
10/11/2015
Date registered
18/11/2015
Titles & IDs
Public title
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
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Scientific title
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
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Secondary ID [1]
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0
2015-003988-10
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Secondary ID [2]
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GS-US-380-1490
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - DTG
Treatment: Drugs - F/TAF
Treatment: Drugs - B/F/TAF
Treatment: Drugs - DTG Placebo
Treatment: Drugs - F/TAF Placebo
Treatment: Drugs - B/F/TAF Placebo
Experimental: B/F/TAF - B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks.
Active comparator: DTG + F/TAF - DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks.
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.
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.
Treatment: Drugs: DTG
50 mg tablets administered orally, once daily
Treatment: Drugs: F/TAF
200/25 mg tablets administered orally, once daily
Treatment: Drugs: B/F/TAF
50/200/25 milligrams (mg) FDC tablets administered orally, once daily
Treatment: Drugs: DTG Placebo
Tablets administered orally, once daily
Treatment: Drugs: F/TAF Placebo
Tablets administered orally, once daily
Treatment: Drugs: B/F/TAF Placebo
Tablets administered orally, once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
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Assessment method [1]
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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.
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Timepoint [1]
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Week 48
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Secondary outcome [1]
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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
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Assessment method [1]
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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.
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Timepoint [1]
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Week 96
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Secondary outcome [2]
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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
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Assessment method [2]
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0
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.
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Timepoint [2]
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0
Week 144
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Secondary outcome [3]
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Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
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Assessment method [3]
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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.
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Timepoint [3]
0
0
Week 48
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Secondary outcome [4]
0
0
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
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Assessment method [4]
0
0
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.
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Timepoint [4]
0
0
Week 96
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Secondary outcome [5]
0
0
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
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Assessment method [5]
0
0
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.
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Timepoint [5]
0
0
Week 144
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Secondary outcome [6]
0
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Change From Baseline in log10 HIV-1 RNA at Week 48
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Assessment method [6]
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0
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Timepoint [6]
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Baseline, Week 48
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Secondary outcome [7]
0
0
Change From Baseline in log10 HIV-1 RNA at Week 96
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Assessment method [7]
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0
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Timepoint [7]
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Baseline, Week 96
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Secondary outcome [8]
0
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Change From Baseline in log10 HIV-1 RNA at Week 144
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Assessment method [8]
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Timepoint [8]
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Baseline, Week 144
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Secondary outcome [9]
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Change From Baseline in CD4+ Cell Count at Week 48
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Assessment method [9]
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0
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Timepoint [9]
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Baseline, Week 48
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Secondary outcome [10]
0
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Change From Baseline in CD4+ Cell Count at Week 96
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Assessment method [10]
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Timepoint [10]
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Baseline, Week 96
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Secondary outcome [11]
0
0
Change From Baseline in CD4+ Cell Count at Week 144
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Assessment method [11]
0
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Timepoint [11]
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Baseline, Week 144
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Secondary outcome [12]
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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm
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Assessment method [12]
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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.
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Timepoint [12]
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0
Baseline, open-label Week 48
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Secondary outcome [13]
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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm
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Assessment method [13]
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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.
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Timepoint [13]
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0
Baseline, open-label Week 48
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Secondary outcome [14]
0
0
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm
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Assessment method [14]
0
0
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.
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Timepoint [14]
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0
Baseline, open-label Week 96
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Secondary outcome [15]
0
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Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm
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Assessment method [15]
0
0
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.
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Timepoint [15]
0
0
Baseline, open-label Week 96
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Secondary outcome [16]
0
0
Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
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Assessment method [16]
0
0
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Timepoint [16]
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0
Baseline, open-label Week 48
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Secondary outcome [17]
0
0
Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
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Assessment method [17]
0
0
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Timepoint [17]
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0
Baseline, open-label Week 96
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/11/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/07/2021
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Sample size
Target
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Accrual to date
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Final
657
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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- Sydney
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Recruitment hospital [2]
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- Carlton
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Recruitment hospital [3]
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- Clayton
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Recruitment hospital [4]
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- Melbourne
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Recruitment hospital [5]
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- Prahran
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Recruitment hospital [6]
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Prahran Market Clinic - Prahran
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Recruitment postcode(s) [1]
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2010 NSW - Sydney
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Recruitment postcode(s) [2]
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3053 - Carlton
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Recruitment postcode(s) [3]
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3168 - Clayton
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3004 - Melbourne
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Recruitment postcode(s) [5]
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3068 - Prahran
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Recruitment postcode(s) [6]
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3181 - Prahran
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Ottawa
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Alicante
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Vigo
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02607956
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Trial related presentations / publications
Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E, Stellbrink HJ, Antinori A, Workowski K, Slim J, Reynes J, Garner W, Custodio J, White K, SenGupta D, Cheng A, Quirk E. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2073-2082. doi: 10.1016/S0140-6736(17)32340-1. Epub 2017 Aug 31. Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223. Stellbrink HJ, Arribas JR, Stephens JL, Albrecht H, Sax PE, Maggiolo F, Creticos C, Martorell CT, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e364-e372. doi: 10.1016/S2352-3018(19)30080-3. Epub 2019 May 5. Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, Lutz J, Majeed S, SenGupta D, Martin H, Quirk E, White KL. Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks. Antimicrob Agents Chemother. 2019 Apr 25;63(5):e02533-18. doi: 10.1128/AAC.02533-18. Print 2019 May. Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in ART-naive participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy outcome. [Poster MOPEB242]. 10th IAS Conference on HIV Science (IAS 2019); 2019 July 21-24; Mexico City, Mexico. Johnson M, Taylor S, Wei X, Collins SE, Martin H. Hepatic Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide [Poster P061]. 25th Annual Conference of the British HIV Association; 2019 02-05 April; Bournemouth, United Kingdom. Gupta S, Mills A, Brinson C, Workowski K, Clarke A, Antinori A, et al. 96 Week Efficacy and Safety of B/F/TAF in Treatment-Naïve Adults and Adults =50 Years [Poster 502]. CROI 2019; 2019 04-07 March; Seattle, WA. Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naïve or switch studies. [Poster THPEB077]. 22nd International AIDS Conference; 2018 July 23-27; Amsterdam, Netherlands. White K, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patients. [Poster 532]. Conference on Retroviruses and Opportunistic Infections; 2018 March 4-7; Boston, USA. Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8. Wohl DA, Yazdanpanah Y, Baumgarten A, Clarke A, Thompson MA, Brinson C, Hagins D, Ramgopal MN, Antinori A, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e355-e363. doi: 10.1016/S2352-3018(19)30077-3. Epub 2019 May 5. Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. HIV Viral Blips in Adults Treated with INSTI-Based Regimens Through 144 Weeks. [Poster 540]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts. Mills A, Gupta SK, Brinson C, Workowski K, Clarke A, Antinori A, Stephens JL, et al. 144-Week Efficacy and Safety of B/F/TAF in Treatment-Naive Adults Age =50 Years. [Poster 477]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts. Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, Martorell C, Stephens JL, Stellbrink HJ, Wohl D, Maggiolo F, Thompson MA, Podzamczer D, Hagins D, Flamm JA, Brinson C, Clarke A, Huang H, Acosta R, Brainard DM, Collins SE, Martin H; GS-US-380-1489; GS-US-380-1490 study investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020 Jun;7(6):e389-e400. doi: 10.1016/S2352-3018(20)30099-0. Ramgopal M, Maggiolo F, Ward D, Leboucche B, Rizzardini G, Molina JM, et al. Pooled Analysis of 4 International Trials of Bictegravir/Emtrictabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged = 65 Years Demonstrating Safety and Efficacy: Week 48 Results. [Oral OAB0403].AIDS 2020; 2020 July 6-10; Virtual. Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV Drug Therapy 2020 (HIV Glasgow 2020); 2020 October 5-8; Glasgow, United Kingdom. Acosta R, Chen G, Chang S, Martin R, Wang X, Huang H, et al. HIV with Transmitted Drug Resistance Is Durably Suppressed by B/F/TAF at Week 144. [Poster 430]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual. Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Huang H, Brainard D, Collins SE, Martin H, White KL. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants. J Antimicrob Chemother. 2021 Jul 15;76(8):2153-2157. doi: 10.1093/jac/dkab115. Workowski K, Orkin C, Sax P, Hagins D, Koenig E, Stephens JL, et al. Four-Year Outcomes of B/F/TAF in Treatment-Naïve Adults [Poster 415]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual. Acosta R, Chen G, Qin L, Wang X, Huang H, Hindman J, et al. Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naive Clinical Trials. [Poster PEB150]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual. Acosta R, Chen G, Huang H, Liu H, White K. Unreturned Pill Bottles in the 1489 and 1490 Clinical Trials: An Important Measure of Poor Adherence That Is Often Ignored in Pill Count Calculations. [Poster 902]. IDWeek 2021; 2021 September 29-October 3; Virtual. Arribas J, Orkin C, Maggiolo F, Antinori A, Lazzarin A, Yasdanpanah, et al. Long-term Analysis of B/F/TAF in Treatment-Naïve Adults Living With HIV Through Four Years of Follow-up. [PEB151]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual. Daar E, Orkin C, Sax P, Stephens J, Koenig E, Clarke A, et al. Incidence of Metabolic Complications Among Treatment-naïve Adults Living With HIV-1 Randomized to B/F/TAF, DTG/ABC/3TC or DTG+F/TAF After 3 Years. [Oral 69]. IDWeek 2021; 2021 September 29- October 3; Virtual. Pozniak A, et al. Outcomes 48 Weeks After Switching From DTG/ABC/3TC or DTG+F/TAF to B/F/TAF. [PE2/68]. 18th European AIDS Conference (EAC 2021), 2021 October 27-30; London, United Kingdom.
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Public notes
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Contacts
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Gilead Study Director
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Gilead Sciences
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
18 months after study completion
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Available to whom?
A secured external environment with username, password, and RSA code.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
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What supporting documents are/will be available?
No Supporting Document Provided
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Attachment
Study protocol
Study Protocol: Original
https://cdn.clinicaltrials.gov/large-docs/56/NCT02607956/Prot_004.pdf
Study protocol
Study Protocol: Amendment 1
https://cdn.clinicaltrials.gov/large-docs/56/NCT02607956/Prot_005.pdf
Study protocol
Study Protocol: Amendment 2
https://cdn.clinicaltrials.gov/large-docs/56/NCT02607956/Prot_006.pdf
Study protocol
Study Protocol: Amendment 3
https://cdn.clinicaltrials.gov/large-docs/56/NCT02607956/Prot_008.pdf
Statistical analysis plan
Statistical Analysis Plan: Original
https://cdn.clinicaltrials.gov/large-docs/56/NCT02607956/SAP_007.pdf
Statistical analysis plan
Statistical Analysis Plan: Amendment 1
https://cdn.clinicaltrials.gov/large-docs/56/NCT02607956/SAP_009.pdf
Statistical analysis plan
Statistical Analysis Plan: Final Analysis
https://cdn.clinicaltrials.gov/large-docs/56/NCT02607956/SAP_010.pdf
Results publications and other study-related documents
Type
Citations or Other Details
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Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E,...
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Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA...
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Stellbrink HJ, Arribas JR, Stephens JL, Albrecht H...
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Acosta RK, Willkom M, Martin R, Chang S, Wei X, Ga...
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Acosta R, Willkom M, Martin R, Chang S, Liu X, Hed...
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Johnson M, Taylor S, Wei X, Collins SE, Martin H. ...
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Gupta S, Mills A, Brinson C, Workowski K, Clarke A...
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Acosta R, White K, Garner W, Wei X, Andreatta K, W...
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White K, Kulkarni R, Willkom M, Martin R, Chang S,...
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Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, ...
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Wohl DA, Yazdanpanah Y, Baumgarten A, Clarke A, Th...
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Acosta R, Andreatta K, D'Antoni M, Collins S, Mart...
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Mills A, Gupta SK, Brinson C, Workowski K, Clarke ...
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Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, ...
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Ramgopal M, Maggiolo F, Ward D, Leboucche B, Rizza...
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Acosta R, Andreatta K, D'Antoni M, Collins S, Mart...
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Acosta R, Chen G, Chang S, Martin R, Wang X, Huang...
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Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Hua...
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Workowski K, Orkin C, Sax P, Hagins D, Koenig E, S...
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Acosta R, Chen G, Qin L, Wang X, Huang H, Hindman ...
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Acosta R, Chen G, Huang H, Liu H, White K. Unretur...
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Arribas J, Orkin C, Maggiolo F, Antinori A, Lazzar...
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Daar E, Orkin C, Sax P, Stephens J, Koenig E, Clar...
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Pozniak A, et al. Outcomes 48 Weeks After Switchin...
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Results are available at
https://clinicaltrials.gov/study/NCT02607956