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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/NCT02603107
Registration number
NCT02603107
Ethics application status
Date submitted
10/11/2015
Date registered
11/11/2015
Date last updated
29/12/2020
Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
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Scientific title
A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults
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Secondary ID [1]
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2015-004011-20
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Secondary ID [2]
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GS-US-380-1878
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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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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - RTV
Treatment: Drugs - ATV
Treatment: Drugs - DRV
Treatment: Drugs - COBI
Treatment: Drugs - ATV/co
Treatment: Drugs - DRV/co
Treatment: Drugs - FTC/TDF
Treatment: Drugs - ABC/3TC
Treatment: Drugs - B/F/TAF
Experimental: B/F/TAF - Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for at least 48 weeks, without regard to food.
Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.
Experimental: Stay on Baseline Regimen (SBR) - Randomized Phase: Participants remained on current antiretroviral (ARV) regimen consisting of ritonavir (RTV)-boosted or cobicistat (COBI)-boosted atazanavir (ATV) or darunavir (DRV), plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) for at least 48 weeks with food.
Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.
Treatment: Drugs: RTV
100 mg capsule coadministered orally with ATV or DRV once daily with food
Treatment: Drugs: ATV
300 mg capsule administered orally once daily with food
Treatment: Drugs: DRV
800 mg tablet administered orally once daily with food
Treatment: Drugs: COBI
150 mg tablet coadministered orally with ATV or DRV once daily with food
Treatment: Drugs: ATV/co
300/150 mg FDC tablet administered orally once daily with food
Treatment: Drugs: DRV/co
800/150 mg FDC tablet administered orally once daily with food
Treatment: Drugs: FTC/TDF
200/300 mg FDC tablet administered orally once daily without regard to food
Treatment: Drugs: ABC/3TC
600/300 mg tablet administered orally once daily with or without regard to food
Treatment: Drugs: B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food
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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 With HIV-1 RNA = 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
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Assessment method [1]
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The percentage of participants with 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 With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
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Assessment method [1]
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The percentage of participants with 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 [2]
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Change From Baseline in CD4 Cell Count at Week 48
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Assessment method [2]
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Timepoint [2]
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Baseline to Week 48
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Eligibility
Key inclusion criteria
Key
- Currently receiving a once daily antiretroviral regimen consisting of ritonavir or
cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC for = 6 months preceding
the screening visit
- Adequate renal function:
- Estimated glomerular filtration rate = 50 mL/min (= 0.83 mL/sec) according to the
Cockcroft-Gault formula
- Life expectancy = 1 year
- Currently on a stable regimen for = 6 months preceding the screening visit with
documented plasma HIV-1 RNA < 50 copies/mL for = 6 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). Prior changes in antiretroviral regimen are
only allowed due to tolerability issues or for regimen simplification. Unconfirmed
virologic elevations of = 50 copies/mL (transient detectable viremia, or "blip") prior
to screening are acceptable. (If the lower limit of detection of the local HIV-1 RNA
assay is < 50 copies/mL [e.g., < 20 copies/mL], the plasma HIV-1 RNA level cannot
exceed 50 copies/mL on two consecutive HIV-1 RNA tests)
- Have no documented or suspected resistance to FTC, tenofovir, ABC or 3TC, including
but not limited to the reverse transcriptase resistance mutations K65R and M184V/I
- No previous use of any approved or experimental integrase strand transfer inhibitor
(INSTI)
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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
- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or
variceal bleeding)
- Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3
months of study screening, or expected to receive these agents or systemic steroids
during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine
based therapies)
- Current alcohol or substance use judged by the Investigator to potentially interfere
with subject study compliance
- A history of or ongoing malignancy (including untreated carcinoma in-situ) other than
cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive
cutaneous squamous carcinoma. Individuals with biopsy-confirmed cutaneous KS are
eligible, but must not have received any systemic therapy for KS within 30 days of Day
1 and are not anticipated to require systemic therapy during the study
- Active, serious infections (other than HIV 1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to Day 1
- Participation in any other clinical trial, including observational studies, without
prior approval from the sponsor is prohibited while participating in this trial
- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the individual unsuitable for the study or unable to comply
with the dosing requirements
- Any known allergies to the excipients of B/F/TAF FDC or ATV, RTV, DRV, COBI, FTC/TDF
or ABC/3TC
- Females who are pregnant (as confirmed by positive serum pregnancy test)
- Females who are breastfeeding
- Acute hepatitis in the 30 days prior to study entry
- Chronic hepatitis B infection in individuals not on a TDF containing regimen, as
determined by either:
- Positive hepatitis B virus (HBV) surface antigen and negative HBV surface
antibody, regardless of HBV core antibody status, at the screening visit
- Positive HBV core antibody and negative HBV surface antibody, regardless of HBV
surface antigen status, at the screening visit
- Active tuberculosis infection
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
Open (masking not used)
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Who is / are masked / blinded?
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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
20/11/2015
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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
23/12/2019
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Sample size
Target
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Accrual to date
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Final
578
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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- Darlinghurst
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- Sydney
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- Fitzroy
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- Melbourne
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Recruitment hospital [5]
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- Prahran
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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2010 - Sydney
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Recruitment postcode(s) [3]
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3068 - Fitzroy
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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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3141 - Prahran
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Recruitment outside Australia
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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
The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose
combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus
continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in
HIV-1 infected adults who are virologically suppressed.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02603107
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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/NCT02603107
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