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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02607956




Registration number
NCT02607956
Ethics application status
Date submitted
10/11/2015
Date registered
18/11/2015
Date last updated
22/05/2019

Titles & IDs
Public title
Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
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-Naïve Adults
Secondary ID [1] 0 0
2015-003988-10
Secondary ID [2] 0 0
GS-US-380-1490
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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: Blinded Phase: B/F/TAF - B/F/TAF + DTG placebo + F/TAF placebo for at least 144 weeks

Experimental: Blinded Phase: DTG+F/TAF - DTG+F/TAF + B/F/TAF placebo for at least 144 weeks

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 48 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.


Treatment: Drugs: DTG
50 mg tablets administered orally, once daily, without regard to food

Treatment: Drugs: F/TAF
200/25 mg tablets administered orally, once daily, without regard to food

Treatment: Drugs: B/F/TAF
50/200/25 mg FDC tablets administered orally, once daily, without regard to food

Treatment: Drugs: DTG Placebo
Tablets administered orally, once daily, without regard to food

Treatment: Drugs: F/TAF Placebo
Tablets administered orally, once daily, without regard to food

Treatment: Drugs: B/F/TAF Placebo
Tablets administered orally, once daily, without regard to food

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm - 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.
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm - 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.
Timepoint [1] 0 0
Week 96
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
Timepoint [2] 0 0
Week 144
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm - 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.
Timepoint [3] 0 0
Week 48
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 - 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.
Timepoint [4] 0 0
Week 96
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
Timepoint [5] 0 0
Week 144
Secondary outcome [6] 0 0
Change From Baseline in log10 HIV-1 RNA at Week 48
Timepoint [6] 0 0
Baseline; Week 48
Secondary outcome [7] 0 0
Change From Baseline in log10 HIV-1 RNA at Week 96
Timepoint [7] 0 0
Baseline; Week 96
Secondary outcome [8] 0 0
Change From Baseline in log10 HIV-1 RNA at Week 144
Timepoint [8] 0 0
Baseline; Week 144
Secondary outcome [9] 0 0
Change From Baseline in CD4+ Cell Count at Week 48
Timepoint [9] 0 0
Baseline; Week 48
Secondary outcome [10] 0 0
Change From Baseline in CD4+ Cell Count at Week 96
Timepoint [10] 0 0
Baseline; Week 96
Secondary outcome [11] 0 0
Change From Baseline in CD4+ Cell Count at Week 144
Timepoint [11] 0 0
Baseline; Week 144

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 RNA levels = 500 copies/mL at screening

- Adequate renal function: Estimated glomerular filtration rate = 30 mL/min (= 0.50
mL/sec) according to the Cockcroft-Gault formula

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Carlton
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Prahran
Recruitment postcode(s) [1] 0 0
2010 NSW - Sydney
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3068 - Prahran
Recruitment postcode(s) [6] 0 0
3141 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Belgium
State/province [22] 0 0
Antwerp
Country [23] 0 0
Belgium
State/province [23] 0 0
Ghent
Country [24] 0 0
Canada
State/province [24] 0 0
Montreal
Country [25] 0 0
Canada
State/province [25] 0 0
Ottawa
Country [26] 0 0
Canada
State/province [26] 0 0
Toronto
Country [27] 0 0
Canada
State/province [27] 0 0
Winnipeg
Country [28] 0 0
Dominican Republic
State/province [28] 0 0
Santo Domingo
Country [29] 0 0
France
State/province [29] 0 0
Montpellier
Country [30] 0 0
France
State/province [30] 0 0
Nice
Country [31] 0 0
France
State/province [31] 0 0
Tourcoing
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Düsseldorf
Country [34] 0 0
Germany
State/province [34] 0 0
Essen
Country [35] 0 0
Germany
State/province [35] 0 0
Frankfurt
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Germany
State/province [37] 0 0
Köln
Country [38] 0 0
Germany
State/province [38] 0 0
München
Country [39] 0 0
Italy
State/province [39] 0 0
Bergamo
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Roma
Country [42] 0 0
Puerto Rico
State/province [42] 0 0
San Juan
Country [43] 0 0
Spain
State/province [43] 0 0
Alicante
Country [44] 0 0
Spain
State/province [44] 0 0
Badalona
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
Malaga
Country [47] 0 0
Spain
State/province [47] 0 0
Vigo
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Birmingham
Country [49] 0 0
United Kingdom
State/province [49] 0 0
London
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

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 at Week 48.
Trial website
https://clinicaltrials.gov/show/NCT02607956
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications