Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
NCT ID: NCT02397694
Last Updated: 2020-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
98 participants
INTERVENTIONAL
2015-03-23
2019-02-27
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
DOUBLE
Study Groups
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BIC + F/TAF
Participants will receive BIC + F/TAF FDC + DTG placebo for 48 weeks.
* Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
BIC
75 mg tablet administered orally once daily
F/TAF
200/25 mg FDC tablet administered orally once daily
DTG Placebo
Tablet administered orally once daily
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily
DTG + F/TAF
Participants will receive DTG + F/TAF FDC + BIC placebo for 48 weeks.
* Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive B/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
F/TAF
200/25 mg FDC tablet administered orally once daily
DTG
50 mg tablet administered orally once daily
BIC Placebo
Tablet administered orally once daily
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily
Open Label Extension Phase
After Week 48 participants continued to take their randomized study drug and attended visits every 12 weeks until treatment assignments were unblinded, at which point all participants returned for an unblinding visit and were given the option to participate in an open-label rollover extension to receive an FDC containing B/F/TAF.
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily
Interventions
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BIC
75 mg tablet administered orally once daily
F/TAF
200/25 mg FDC tablet administered orally once daily
DTG
50 mg tablet administered orally once daily
BIC Placebo
Tablet administered orally once daily
DTG Placebo
Tablet administered orally once daily
B/F/TAF
50/200/25 mg FDC tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
* Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC)
* Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula
* CD4+ cell count ≥ 200 cells/µL at screening
Exclusion Criteria
* Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP)
* Chronic hepatitis B virus (HBV) infection
* Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible)
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
* Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial
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
Los Angeles, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Boston, Massachusetts, United States
Berkley, Michigan, United States
Newark, New Jersey, United States
Austin, 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
Countries
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References
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Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Peloquin J, Wei X, White K, Cheng A, Martin H, Quirk E. Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. Lancet HIV. 2017 Apr;4(4):e154-e160. doi: 10.1016/S2352-3018(17)30016-4. Epub 2017 Feb 15.
Sax PE, DeJesus E, Crofoot G, Ward D, Benson P, Dretler R, Mills A, Brinson C, Wei X, Collins SE, Cheng A. Coformulated bictegravir, emtricitabine, tenofovir alafenamide after initial treatment with bictegravir or dolutegravir and emtricitabine/tenofovir alafenamide. AIDS. 2018 Jul 31;32(12):1723-1725. doi: 10.1097/QAD.0000000000001894.
Other Identifiers
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GS-US-141-1475
Identifier Type: -
Identifier Source: org_study_id
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