Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

NCT02607956 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: GS-US-380-14902015-003988-10
• Study Type: interventional
• Target: 657
• Locations: 11 countries
• Sites: 125

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.

Conditions

HIV-1 Infection

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 48

Secondary Outcomes (17)

• Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

  Week 96

• Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

  Week 144

• Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

  Week 48

• Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

  Week 96

• Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

  Week 144

Study Arms (4)

B/F/TAF

EXPERIMENTAL

B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks.

Drug: B/F/TAF; Drug: DTG Placebo; Drug: F/TAF Placebo

DTG + F/TAF

ACTIVE COMPARATOR

DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks.

Drug: DTG; Drug: F/TAF; Drug: B/F/TAF Placebo

Open-label Phase B/F/TAF from B/F/TAF

EXPERIMENTAL

After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

Drug: B/F/TAF

Open-label Phase B/F/TAF from DTG + F/TAF

EXPERIMENTAL

After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

Drug: B/F/TAF

Interventions

DTG DRUG

50 mg tablets administered orally, once daily

Also known as: Tivicay®

DTG + F/TAF

F/TAF DRUG

200/25 mg tablets administered orally, once daily

Also known as: Descovy®

DTG + F/TAF

B/F/TAF DRUG

50/200/25 milligrams (mg) FDC tablets administered orally, once daily

Also known as: GS-9883/F/TAF, Biktarvy®

B/F/TAF; Open-label Phase B/F/TAF from B/F/TAF; Open-label Phase B/F/TAF from DTG + F/TAF

DTG Placebo DRUG

Tablets administered orally, once daily

B/F/TAF

F/TAF Placebo DRUG

Tablets administered orally, once daily

B/F/TAF

B/F/TAF Placebo DRUG

Tablets administered orally, once daily

DTG + F/TAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening
• Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL per minute (min) (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (125)

Unknown Facility

Phoenix, Arizona, 85012, United States

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Unknown Facility

Phoenix, Arizona, 85025, United States

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Unknown Facility

Beverly Hills, California, 90211, United States

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Unknown Facility

Los Angeles, California, 90027, United States

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Unknown Facility

Los Angeles, California, 90036, United States

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Unknown Facility

Los Angeles, California, 90059, United States

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Unknown Facility

Los Angeles, California, 90069, United States

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Unknown Facility

Sacramento, California, 95817, United States

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Unknown Facility

Sacramento, California, 95825, United States

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Optimus Medical - ClinEdge - PPDS

San Francisco, California, 94102, United States

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Kaiser Permanente

San Leandro, California, 94577, United States

Location

Unknown Facility

Denver, Colorado, 80205, United States

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Unknown Facility

Washington D.C., District of Columbia, 20009, United States

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Unknown Facility

Washington D.C., District of Columbia, 20036, United States

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Unknown Facility

Washington D.C., District of Columbia, 20037, United States

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Unknown Facility

DeLand, Florida, 32720, United States

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Unknown Facility

Fort Lauderdale, Florida, 33316, United States

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Unknown Facility

Ft. Pierce, Florida, 34982, United States

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Unknown Facility

Miami, Florida, 33133, United States

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Unknown Facility

Miami, Florida, 33136, United States

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Unknown Facility

Miami Beach, Florida, 33139, United States

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Unknown Facility

Oakland Park, Florida, 33306, United States

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Unknown Facility

Orlando, Florida, 32803, United States

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Unknown Facility

Pensacola, Florida, 32504, United States

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Unknown Facility

Tampa, Florida, 33614, United States

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Unknown Facility

West Palm Beach, Florida, 33407, United States

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Unknown Facility

Atlanta, Georgia, 30308, United States

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Unknown Facility

Atlanta, Georgia, 30312, United States

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Unknown Facility

Decatur, Georgia, 30033, United States

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Unknown Facility

Macon, Georgia, 31201, United States

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Unknown Facility

Savannah, Georgia, 31405, United States

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Unknown Facility

Chicago, Illinois, 60613, United States

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Unknown Facility

Chicago, Illinois, 60657, United States

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Unknown Facility

Indianapolis, Indiana, 46202, United States

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Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

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Unknown Facility

Boston, Massachusetts, 02129, United States

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Unknown Facility

Boston, Massachusetts, 02215, United States

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Unknown Facility

Springfield, Massachusetts, 01105, United States

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Unknown Facility

Berkley, Michigan, 48072, United States

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Unknown Facility

Detroit, Michigan, 48202, United States

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Kansas City, Missouri, 64111, United States

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Unknown Facility

St Louis, Missouri, 63108, United States

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Unknown Facility

St Louis, Missouri, 63139, United States

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Unknown Facility

Hillsborough, New Jersey, 08844, United States

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Newark, New Jersey, 07102, United States

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Albany, New York, 12208, United States

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Manhasset, New York, 11030, United States

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Unknown Facility

New York, New York, 10011-4121, United States

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Unknown Facility

New York, New York, 10011, United States

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Unknown Facility

The Bronx, New York, 10461, United States

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Unknown Facility

Chapel Hill, North Carolina, 27514, United States

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Unknown Facility

Charlotte, North Carolina, 28207, United States

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Cone Health Regional Center for Infectious Disease

Greensboro, North Carolina, 27401, United States

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Unknown Facility

Greenville, North Carolina, 27858-4354, United States

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Unknown Facility

Huntersville, North Carolina, 28078, United States

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Unknown Facility

Winston-Salem, North Carolina, 27157, United States

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Unknown Facility

Cincinnati, Ohio, 45267, United States

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Philadelphia, Pennsylvania, 19104, United States

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Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

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Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

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Columbia, South Carolina, 29203-6840, United States

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Unknown Facility

Austin, Texas, 78705, United States

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Unknown Facility

Bellaire, Texas, 77401, United States

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Unknown Facility

Dallas, Texas, 75202, United States

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AIDS Arms Inc

Dallas, Texas, 75215, United States

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Unknown Facility

Dallas, Texas, 75235, United States

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North Texas Infectious Diseases Consultants PA

Dallas, Texas, 75246, United States

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Unknown Facility

Fort Worth, Texas, 76104, United States

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Houston, Texas, 77004, United States

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Houston, Texas, 77098, United States

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Longview, Texas, 75605, United States

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Annandale, Virginia, 22003-7313, United States

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Seattle, Washington, 98104, United States

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Unknown Facility

Spokane, Washington, 99204, United States

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Sydney, New South Wales, 2010 NSW, Australia

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Carlton, Victoria, 3053, Australia

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Clayton, Victoria, 3168, Australia

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Unknown Facility

Melbourne, Victoria, 3004, Australia

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Prahran, Victoria, 3068, Australia

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Prahran Market Clinic

Prahran, Victoria, 3181, Australia

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Unknown Facility

Antwerp, 2000, Belgium

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Unknown Facility

Ghent, B-9000, Belgium

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McGill University Health Center

Montreal, H4A 3J1, Canada

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Unknown Facility

Ottawa, K1H 8L6, Canada

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Sunnybrook Health Sciences Centre

Toronto, M4N 3M5, Canada

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Toronto, M5G 1K2, Canada

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Toronto, M5G2N2, Canada

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Winnipeg, R3A 1R9, Canada

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Santo Domingo, 10103, Dominican Republic

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Unknown Facility

Montpellier, 34295, France

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CHU de Nice Archet I

Nice, 06200, France

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Unknown Facility

Tourcoing, 59200, France

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Unknown Facility

Tourcoing, 59208, France

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Unknown Facility

Berlin, 12157, Germany

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Uniklinik Köln

Cologne, 50924, Germany

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Unknown Facility

Düsseldorf, 40237, Germany

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Unknown Facility

Essen, 45122, Germany

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Unknown Facility

Frankfurt, 60311, Germany

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Unknown Facility

Frankfurt, 60590, Germany

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Hamburg, 20146, Germany

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München, 80335, Germany

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Unknown Facility

Bergamo, 24127, Italy

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Milan, 20127, Italy

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Roma, Italy

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San Juan, 00909-1711, Puerto Rico

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Unknown Facility

San Juan, 00909, Puerto Rico

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Unknown Facility

Alicante, 3010, Spain

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Unknown Facility

Badalona, 08907, Spain

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Unknown Facility

Madrid, 28007, Spain

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Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

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Unknown Facility

Madrid, 28034, Spain

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Unknown Facility

Madrid, 28046, Spain

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Unknown Facility

Málaga, 29010, Spain

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Unknown Facility

Vigo, 36312, Spain

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Unknown Facility

Birmingham, B4 6DH, United Kingdom

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Unknown Facility

Birmingham, B9 5SS, United Kingdom

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Unknown Facility

London, E1 1BB., United Kingdom

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Unknown Facility

London, NW3 2QG, United Kingdom

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Unknown Facility

London, SE19 3ST, United Kingdom

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Unknown Facility

London, SE5 9RJ, United Kingdom

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Chelsea and Westminster NHS Trust

London, SW10 9NH, United Kingdom

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St George's Healthcare NHS Trust

London, SW17 0QT, United Kingdom

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Unknown Facility

London, WC1E 6JB, United Kingdom

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Unknown Facility

Manchester, M13 0FH, United Kingdom

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Unknown Facility

Manchester, M8 5RB, United Kingdom

Location

Related Publications (27)

• Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E, Stellbrink HJ, Antinori A, Workowski K, Slim J, Reynes J, Garner W, Custodio J, White K, SenGupta D, Cheng A, Quirk E. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2073-2082. doi: 10.1016/S0140-6736(17)32340-1. Epub 2017 Aug 31.

  PMID: 28867499 RESULT

• Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

  PMID: 30932951 RESULT

• Stellbrink HJ, Arribas JR, Stephens JL, Albrecht H, Sax PE, Maggiolo F, Creticos C, Martorell CT, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e364-e372. doi: 10.1016/S2352-3018(19)30080-3. Epub 2019 May 5.

  PMID: 31068272 RESULT

• Acosta RK, Willkom M, Martin R, Chang S, Wei X, Garner W, Lutz J, Majeed S, SenGupta D, Martin H, Quirk E, White KL. Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks. Antimicrob Agents Chemother. 2019 Apr 25;63(5):e02533-18. doi: 10.1128/AAC.02533-18. Print 2019 May.

  PMID: 30803969 RESULT

• Acosta R, Willkom M, Martin R, Chang S, Liu X, Hedskog C, et al. Low-frequency resistance variants in ART-naive participants do not affect bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) triple therapy outcome. [Poster MOPEB242]. 10th IAS Conference on HIV Science (IAS 2019); 2019 July 21-24; Mexico City, Mexico.

  RESULT

• Johnson M, Taylor S, Wei X, Collins SE, Martin H. Hepatic Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide [Poster P061]. 25th Annual Conference of the British HIV Association; 2019 02-05 April; Bournemouth, United Kingdom.

  RESULT

• Gupta S, Mills A, Brinson C, Workowski K, Clarke A, Antinori A, et al. 96 Week Efficacy and Safety of B/F/TAF in Treatment-Naïve Adults and Adults ≥50 Years [Poster 502]. CROI 2019; 2019 04-07 March; Seattle, WA.

  RESULT

• Acosta R, White K, Garner W, Wei X, Andreatta K, Willkom M, et al. HIV-1 subtype (B or non-B) had no impact on the efficacy of B/F/TAF or resistance development in five phase 3 treatment-naïve or switch studies. [Poster THPEB077]. 22nd International AIDS Conference; 2018 July 23-27; Amsterdam, Netherlands.

  RESULT

• White K, Kulkarni R, Willkom M, Martin R, Chang S, Wei X, et al. Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naive patients. [Poster 532]. Conference on Retroviruses and Opportunistic Infections; 2018 March 4-7; Boston, USA.

  RESULT

• Wohl D, Clarke A, Maggiolo F, Garner W, Laouri M, Martin H, Quirk E. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. Patient. 2018 Oct;11(5):561-573. doi: 10.1007/s40271-018-0322-8.

  PMID: 29956087 RESULT

• Wohl DA, Yazdanpanah Y, Baumgarten A, Clarke A, Thompson MA, Brinson C, Hagins D, Ramgopal MN, Antinori A, Wei X, Acosta R, Collins SE, Brainard D, Martin H. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019 Jun;6(6):e355-e363. doi: 10.1016/S2352-3018(19)30077-3. Epub 2019 May 5.

  PMID: 31068270 RESULT

• Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. HIV Viral Blips in Adults Treated with INSTI-Based Regimens Through 144 Weeks. [Poster 540]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.

  RESULT

• Mills A, Gupta SK, Brinson C, Workowski K, Clarke A, Antinori A, Stephens JL, et al. 144-Week Efficacy and Safety of B/F/TAF in Treatment-Naive Adults Age ≥50 Years. [Poster 477]. Conference on Retroviruses and Opportunistic Infections 2020 (CROI 2020); 2020 March 8-11; Boston, Massachusetts.

  RESULT

• Orkin C, DeJesus E, Sax PE, Arribas JR, Gupta SK, Martorell C, Stephens JL, Stellbrink HJ, Wohl D, Maggiolo F, Thompson MA, Podzamczer D, Hagins D, Flamm JA, Brinson C, Clarke A, Huang H, Acosta R, Brainard DM, Collins SE, Martin H; GS-US-380-1489; GS-US-380-1490 study investigators. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020 Jun;7(6):e389-e400. doi: 10.1016/S2352-3018(20)30099-0.

  PMID: 32504574 RESULT

• Ramgopal M, Maggiolo F, Ward D, Leboucche B, Rizzardini G, Molina JM, et al. Pooled Analysis of 4 International Trials of Bictegravir/Emtrictabine/Tenofovir Alafenamide (B/F/TAF) in Adults Aged ≥ 65 Years Demonstrating Safety and Efficacy: Week 48 Results. [Oral OAB0403].AIDS 2020; 2020 July 6-10; Virtual.

  RESULT

• Acosta R, Andreatta K, D'Antoni M, Collins S, Martin H, White K. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV Drug Therapy 2020 (HIV Glasgow 2020); 2020 October 5-8; Glasgow, United Kingdom.

  RESULT

• Acosta R, Chen G, Chang S, Martin R, Wang X, Huang H, et al. HIV with Transmitted Drug Resistance Is Durably Suppressed by B/F/TAF at Week 144. [Poster 430]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.

  RESULT

• Acosta RK, Chen GQ, Chang S, Martin R, Wang X, Huang H, Brainard D, Collins SE, Martin H, White KL. Three-year study of pre-existing drug resistance substitutions and efficacy of bictegravir/emtricitabine/tenofovir alafenamide in HIV-1 treatment-naive participants. J Antimicrob Chemother. 2021 Jul 15;76(8):2153-2157. doi: 10.1093/jac/dkab115.

  PMID: 33880558 RESULT

• Workowski K, Orkin C, Sax P, Hagins D, Koenig E, Stephens JL, et al. Four-Year Outcomes of B/F/TAF in Treatment-Naïve Adults [Poster 415]. Conference on Retroviruses and Opportunistic Infections 2021 (CROI 2021); 2021 June 3-November 3; Virtual.

  RESULT

• Acosta R, Chen G, Qin L, Wang X, Huang H, Hindman J, et al. Achievement of Undetectable HIV-1 RNA in the B/F/TAF Treatment-Naive Clinical Trials. [Poster PEB150]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.

  RESULT

• Acosta R, Chen G, Huang H, Liu H, White K. Unreturned Pill Bottles in the 1489 and 1490 Clinical Trials: An Important Measure of Poor Adherence That Is Often Ignored in Pill Count Calculations. [Poster 902]. IDWeek 2021; 2021 September 29-October 3; Virtual.

  RESULT

• Arribas J, Orkin C, Maggiolo F, Antinori A, Lazzarin A, Yasdanpanah, et al. Long-term Analysis of B/F/TAF in Treatment-Naïve Adults Living With HIV Through Four Years of Follow-up. [PEB151]. 11th IAS Conference on HIV Science (IAS 2021); 2021 July 18-21; Virtual.

  RESULT

• Daar E, Orkin C, Sax P, Stephens J, Koenig E, Clarke A, et al. Incidence of Metabolic Complications Among Treatment-naïve Adults Living With HIV-1 Randomized to B/F/TAF, DTG/ABC/3TC or DTG+F/TAF After 3 Years. [Oral 69]. IDWeek 2021; 2021 September 29- October 3; Virtual.

  RESULT

• Pozniak A, et al. Outcomes 48 Weeks After Switching From DTG/ABC/3TC or DTG+F/TAF to B/F/TAF. [PE2/68]. 18th European AIDS Conference (EAC 2021), 2021 October 27-30; London, United Kingdom.

  RESULT

• Sax PE, Hindman JT, Martin H, Wohl D. Two 5-year studies of bictegravir/emtricitabine/tenofovir alafenamide in people with HIV: a plain-language summary. Future Microbiol. 2024;19(14):1185-1193. doi: 10.1080/17460913.2024.2372231. Epub 2024 Sep 4.

  PMID: 39229805 DERIVED

• Orkin C, Antinori A, Rockstroh JK, Moreno-Guillen S, Martorell CT, Molina JM, Lazzarin A, Maggiolo F, Yazdanpanah Y, Andreatta K, Huang H, Hindman JT, Martin H, Pozniak A. Switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir-based therapy. AIDS. 2024 Jun 1;38(7):983-991. doi: 10.1097/QAD.0000000000003865. Epub 2024 Feb 21.

  PMID: 38349226 DERIVED

• Sax PE, Arribas JR, Orkin C, Lazzarin A, Pozniak A, DeJesus E, Maggiolo F, Stellbrink HJ, Yazdanpanah Y, Acosta R, Huang H, Hindman JT, Martin H, Baeten JM, Wohl D; GS-US-380-1489 and GS-US-380-1490 study investigators. Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials. EClinicalMedicine. 2023 May 11;59:101991. doi: 10.1016/j.eclinm.2023.101991. eCollection 2023 May.

  PMID: 37200995 DERIVED

MeSH Terms

Interventions

dolutegravir; emtricitabine tenofovir alafenamide; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 18, 2015
• Study Start: November 11, 2015
• Primary Completion: May 12, 2017
• Study Completion: July 5, 2021
• Last Updated: March 7, 2022
• Results First Posted: June 6, 2018

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

PR (2); CA (6); BE (2); US (74); DO (1); AU (6); DE (8); IT (3); ES (8); FR (4); GB (11)