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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02607956
Registration number
NCT02607956
Ethics application status
Date submitted
10/11/2015
Date registered
18/11/2015
Date last updated
7/03/2022
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]
0
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]
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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]
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0
Week 144
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Secondary outcome [6]
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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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Timepoint [6]
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Baseline, Week 48
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Secondary outcome [7]
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Change From Baseline in log10 HIV-1 RNA at Week 96
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Assessment method [7]
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Timepoint [7]
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Baseline, Week 96
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Secondary outcome [8]
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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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Timepoint [9]
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Baseline, Week 48
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Secondary outcome [10]
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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]
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Change From Baseline in CD4+ Cell Count at Week 144
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Assessment method [11]
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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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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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Baseline, open-label Week 48
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Secondary outcome [14]
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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]
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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 [14]
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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]
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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 [15]
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Baseline, open-label Week 96
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Secondary outcome [16]
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Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
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Assessment method [16]
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0
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Timepoint [16]
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Baseline, open-label Week 48
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Secondary outcome [17]
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Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
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Assessment method [17]
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0
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Timepoint [17]
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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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Recruitment postcode(s) [4]
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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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Florida
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Alicante
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Vigo
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London
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United Kingdom
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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
Ethics application status
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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/ct2/show/NCT02607956
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02607956
Download to PDF