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
NCT ID: NCT02603107
Last Updated: 2020-12-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
578 participants
INTERVENTIONAL
2015-11-20
2019-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food
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.
RTV
100 mg capsule coadministered orally with ATV or DRV once daily with food
ATV
300 mg capsule administered orally once daily with food
DRV
800 mg tablet administered orally once daily with food
COBI
150 mg tablet coadministered orally with ATV or DRV once daily with food
ATV/co
300/150 mg FDC tablet administered orally once daily with food
DRV/co
800/150 mg FDC tablet administered orally once daily with food
FTC/TDF
200/300 mg FDC tablet administered orally once daily without regard to food
ABC/3TC
600/300 mg tablet administered orally once daily with or without regard to food
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food
Interventions
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RTV
100 mg capsule coadministered orally with ATV or DRV once daily with food
ATV
300 mg capsule administered orally once daily with food
DRV
800 mg tablet administered orally once daily with food
COBI
150 mg tablet coadministered orally with ATV or DRV once daily with food
ATV/co
300/150 mg FDC tablet administered orally once daily with food
DRV/co
800/150 mg FDC tablet administered orally once daily with food
FTC/TDF
200/300 mg FDC tablet administered orally once daily without regard to food
ABC/3TC
600/300 mg tablet administered orally once daily with or without regard to food
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily without regard to food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Phoenix, Arizona, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Oakland, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
San Leandro, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Ft. Pierce, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Vero Beach, Florida, United States
West Palm Beach, Florida, United States
Wilton Manors, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Macon, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Berkley, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Buffalo, New York, United States
The Bronx, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Huntersville, North Carolina, United States
Philadelphia, Pennsylvania, United States
Columbia, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
Annandale, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Darlinghurst, New South Wales, Australia
Sydney, New South Wales, Australia
Fitzroy, Victoria, Australia
Melbourne, Victoria, Australia
Prahran, Victoria, Australia
Brussels, , Belgium
Ghent, , Belgium
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Santo Domingo, , Dominican Republic
Lyon, , France
Nantes, , France
Nice, , France
Paris, , France
Paris, , France
Tourcoing, , France
Tours, , France
Düsseldorf, North Rhine-Westphalia, Germany
Berlin, , Germany
Berlin, , Germany
Bonn, , Germany
Cologne, , Germany
Essen, , Germany
Frankfurt, , Germany
Frankfurt, , Germany
Hamburg, , Germany
München, , Germany
München, , Germany
Milan, , Italy
Milan, , Italy
Roma, , Italy
Ponce, , Puerto Rico
Rio Piedras, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Birmingham, , United Kingdom
Birmingham, , United Kingdom
Brighton, , United Kingdom
Edinburgh, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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Daar ES, DeJesus E, Ruane P, Crofoot G, Oguchi G, Creticos C, Rockstroh JK, Molina JM, Koenig E, Liu YP, Custodio J, Andreatta K, Graham H, Cheng A, Martin H, Quirk E. Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2018 Jul;5(7):e347-e356. doi: 10.1016/S2352-3018(18)30091-2. Epub 2018 Jun 18.
Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J Antimicrob Chemother. 2019 Dec 1;74(12):3555-3564. doi: 10.1093/jac/dkz347.
Avihingsanon A, Chetchotisakd P, Kiertiburanakul S, Ratanasuwan W, Siripassorn K, Supparatpinyo K, Martin H, Wang H, Wong T, Wang HY. Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials. HIV Med. 2023 Mar;24(3):290-300. doi: 10.1111/hiv.13386. Epub 2022 Aug 17.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Statistical Analysis Plan: Week 48
Document Type: Statistical Analysis Plan: Final
Other Identifiers
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2015-004011-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-380-1878
Identifier Type: -
Identifier Source: org_study_id