Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02603120




Registration number
NCT02603120
Ethics application status
Date submitted
10/11/2015
Date registered
11/11/2015

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2015-004025-14
Secondary ID [2] 0 0
GS-US-380-1844
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 - ABC/DTG/3TC
Treatment: Drugs - B/F/TAF
Treatment: Drugs - ABC/DTG/3TC Placebo
Treatment: Drugs - B/F/TAF Placebo

Experimental: Blinded Phase: B/F/TAF - B/F/TAF + ABC/DTG/3TC placebo for at least 48 weeks

Active comparator: Blinded Phase: ABC/DTG/3TC - ABC/DTG/3TC + B/F/TAF placebo for at least 48 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 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.


Treatment: Drugs: ABC/DTG/3TC
600/50/300 mg FDC 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: ABC/DTG/3TC 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 With Virologic Failure (HIV-1 RNA = 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Change From Baseline in CD4+ Cell Count at Week 48
Timepoint [2] 0 0
Baseline; Week 48
Secondary outcome [3] 0 0
Spine Bone Mineral Density (BMD) at Baseline
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Percentage Change From Baseline in Spine BMD at Week 48
Timepoint [4] 0 0
Baseline; Week 48
Secondary outcome [5] 0 0
Hip Bone Mineral Density at Baseline
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Percentage Change From Baseline in Hip BMD at Week 48
Timepoint [6] 0 0
Baseline; Week 48

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/10/2019
Sample size
Target
Accrual to date
Final
567
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
2010 NSW - Sydney
Recruitment postcode(s) [2] 0 0
2010 - Sydney
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
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
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
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
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
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Belgium
State/province [23] 0 0
Ghent
Country [24] 0 0
Canada
State/province [24] 0 0
British Columbia
Country [25] 0 0
Canada
State/province [25] 0 0
Manitoba
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
France
State/province [27] 0 0
Nantes
Country [28] 0 0
France
State/province [28] 0 0
NICE Cedex 03
Country [29] 0 0
France
State/province [29] 0 0
Paris cedex 20
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Bonn
Country [33] 0 0
Germany
State/province [33] 0 0
Essen
Country [34] 0 0
Germany
State/province [34] 0 0
Frankfurt am Main
Country [35] 0 0
Germany
State/province [35] 0 0
Hamburg
Country [36] 0 0
Germany
State/province [36] 0 0
Munich
Country [37] 0 0
Germany
State/province [37] 0 0
München
Country [38] 0 0
Italy
State/province [38] 0 0
Roma
Country [39] 0 0
Puerto Rico
State/province [39] 0 0
San Juan
Country [40] 0 0
Spain
State/province [40] 0 0
Badalona
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Cordoba
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Spain
State/province [44] 0 0
Santiago de Compostela
Country [45] 0 0
Spain
State/province [45] 0 0
Sevilla
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Brighton
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
18 months after study completion
Available to whom?
A secured external environment with username, password, and RSA code.
Available for what types of analyses?
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


What supporting documents are/will be available?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT02603120