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Clinical Trials

MainTitle

Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

This study is ongoing, but not recruiting participants.
Sponsor
Gilead Sciences


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02607956

First received: November 10, 2015
Last updated: May 22, 2017
Last Verified: May 2017
History of Changes
Purpose

Purpose

This study will 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 at Week 48.

Condition Intervention Phase
HIV-1 Infection

Drug : DTG
Drug : F/TAF
Drug : B/F/TAF
Drug : DTG Placebo
Drug : F/TAF Placebo
Drug : B/F/TAF Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Proportion of Participants who Achieve HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]
Secondary Outcome Measures:
  • Proportion of Participants who Achieve HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ]
  • Proportion of Participants who Achieve HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 144 ]
  • Proportion of Participants who Achieve HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]
  • Proportion of Participants who Achieve HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 96 ]
  • Proportion of Participants who Achieve HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 144 ]
  • Change from Baseline in log10 HIV-1 RNA at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Change from Baseline in log10 HIV-1 RNA at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change from Baseline in log10 HIV-1 RNA at Week 144 [ Time Frame: Baseline; Week 144 ]
  • Change from Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Change from Baseline in CD4+ Cell Count at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Change from Baseline in CD4+ Cell Count at Week 144 [ Time Frame: Baseline; Week 144 ]

Enrollment: 645
Study Start Date: November 11, 2015
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: May 12, 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Blinded Phase: B/F/TAF
B/F/TAF + DTG placebo + F/TAF placebo for at least 96 weeks
Drug: B/F/TAF

50/200/25 mg FDC tablets administered orally, once daily, without regard to food

Other Name: GS-9883/F/TAF
Drug: DTG Placebo

Tablets administered orally, once daily, without regard to food

Drug: F/TAF Placebo

Tablets administered orally, once daily, without regard to food

Experimental: Blinded Phase: DTG+F/TAF
DTG+F/TAF + B/F/TAF placebo for at least 96 weeks
Drug: DTG

50 mg tablets administered orally, once daily, without regard to food

Drug: F/TAF

200/25 mg tablets administered orally, once daily, without regard to food

Drug: B/F/TAF Placebo

Tablets administered orally, once daily, without regard to food

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 144 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.
Drug: B/F/TAF

50/200/25 mg FDC tablets administered orally, once daily, without regard to food

Other Name: GS-9883/F/TAF
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Key Inclusion Criteria:

  • Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for PrEP (pre-exposure prophylaxis) or PEP (post-exposure prophylaxis), up to one month prior to screening
  • Plasma HIV 1 RNA levels ≥ 500 copies/mL at screening
  • Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL/min (≥ 0.50 mL/sec) according to the Cockcroft Gault formula

  • Key

Exclusion Criteria:
  • 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02607956

Locations

United States, Arizona
Phoenix, Arizona, United States, 85012
United States, California
Beverly Hills, California, United States, 90211
Los Angeles, California, United States, 90027
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90059
Los Angeles, California, United States, 90069
Sacramento, California, United States, 95187
Sacramento, California, United States, 95825
San Francisco, California, United States, 94102
San Leandro, California, United States, 94577
United States, Colorado
Denver, Colorado, United States, 80205
United States, District of Columbia
Washington, D.C., District of Columbia, United States, 20009
Washington, D.C., District of Columbia, United States, 20036
Washington, D.C., District of Columbia, United States, 20037
United States, Florida
DeLand, Florida, United States, 32720
Fort Lauderdale, Florida, United States, 33305
Fort Lauderdale, Florida, United States, 33316
Fort Pierce, Florida, United States, 34982
Miami Beach, Florida, United States, 33139
Miami, Florida, United States, 33133
Miami, Florida, United States, 33136
Miami, Florida, United States
Orlando, Florida, United States, 32803
Pensacola, Florida, United States, 32504
Tampa, Florida, United States, 33614
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta, Georgia, United States, 30312
Decatur, Georgia, United States, 30033
Macon, Georgia, United States, 31201
Savannah, Georgia, United States, 31401
United States, Illinois
Chicago, Illinois, United States, 60613
Chicago, Illinois, United States, 60657
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Maryland
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Boston, Massachusetts, United States, 02215
Springfield, Massachusetts, United States, 01105
United States, Michigan
Berkley, Michigan, United States, 48072
Detroit, Michigan, United States, 48202
United States, Missouri
Kansas City, Missouri, United States, 64111
Saint Louis, Missouri, United States, 63110
Saint Louis, Missouri, United States, 63139
United States, New Jersey
Hillsborough, New Jersey, United States, 08844
Newark, New Jersey, United States, 07102
United States, New York
Albany, New York, United States, 12208
Manhasset, New York, United States, 11030
New York, New York, United States, 10011-4121
New York, New York, United States, 10011
The Bronx, New York, United States, 10461
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
Charlotte, North Carolina, United States, 28207
Greensboro, North Carolina, United States, 27401
Greenville, North Carolina, United States, 27858-4354
Huntersville, North Carolina, United States, 28078
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron, Ohio, United States, 44304
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19107
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Columbia, South Carolina, United States, 29203-6840
United States, Texas
Austin, Texas, United States, 78705
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75215
Dallas, Texas, United States, 75219
Dallas, Texas, United States, 75235
Dallas, Texas, United States, 75246
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77004
Houston, Texas, United States, 77098
Longview, Texas, United States, 75605
United States, Virginia
Annandale, Virginia, United States, 22003-7313
United States, Washington
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99204
Australia
Sydney, New South Wales, Australia, 2010 NSW
Carlton, Victoria, Australia, 3053
Clayton, Victoria, Australia, 3168
Melbourne, Victoria, Australia, 3004
Prahran, Victoria, Australia, 3141
Victoria, Australia, 3068
Belgium
Antwerp, Belgium, 2000
Ghent, Belgium, B-9000
Canada
Montreal, Canada, H4A 3J1
Ottawa, Canada, K1H 8L6
Toronto, Canada, M4N 3M5
Toronto, Canada, M5G 1K2
Toronto, Canada, M5G2N2
Winnipeg, Canada, R3A 1R9
Dominican Republic
Santo Domingo, Dominican Republic
France
Montpelier Cedex 5, France, 34295
Nice, France, 6200
Tourcoing, France, 59200
Tourcoing, France, 59208
Gabon
Atlanta, United States, Gabon, 30308
Germany
Berlin, Germany, 12157
Düsseldorf, Germany, 40237
Essen, Germany, 45122
Frankfurt, Germany, 60311
Frankfurt, Germany, 60590
Hamburg, Germany, 20146
Köln, Germany, 50924
München, Germany, 80335
Italy
Bergamo, Italy, 24127
Milano, Italy, 20127
Roma, Italy
Puerto Rico
San Juan, Puerto Rico, 00909-1711
San Juan, Puerto Rico, 00909
Spain
Alicante, Spain, 3010
Badalona, Spain, 8907
Madrid, Spain, 28007
Madrid, Spain, 28034
Madrid, Spain, 28046
Malaga, Spain, 29010
Vigo, Spain, 36312
United Kingdom
Birmingham, United Kingdom, B4 6DH
London, United Kingdom, E1 1BB.
London, United Kingdom, NW3 2QG
London, United Kingdom, SE19 3ST
London, United Kingdom, SE5 9RJ
London, United Kingdom, SW10 9TH
London, United Kingdom, SW17 0QT
London, United Kingdom, WC1E 6JB
Manchester, United Kingdom, M13 0FH
Manchester, United Kingdom, M8 5RB
West Midlands, United Kingdom, B9 5SS

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT02607956   History of Changes  
Other Study ID Numbers: GS-US-380-1490  
  2015-003988-10  
Study First Received: November 10, 2015  
Last Updated: May 22, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Gilead Sciences:

HIV

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Dolutegravir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.