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Clinical Trials

MainTitle

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

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


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02607930

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

Purpose

The study will evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.

Condition Intervention Phase
HIV-1 Infection

Drug : ABC/DTG/3TC
Drug : B/F/TAF
Drug : ABC/DTG/3TC 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 Abacavir/Dolutegravir/Lamivudine 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 ]
  • Percentage Change from Baseline in Hip Bone Mineral Density (BMD) at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Percentage Change from Baseline in Hip BMD at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Percentage Change from Baseline in Hip BMD at Week 144 [ Time Frame: Baseline; Week 144 ]
  • Percentage Change from Baseline in Spine BMD at Week 48 [ Time Frame: Baseline; Week 48 ]
  • Percentage Change from Baseline in Spine BMD at Week 96 [ Time Frame: Baseline; Week 96 ]
  • Percentage Change from Baseline in Spine BMD at Week 144 [ Time Frame: Baseline; Week 144 ]

Enrollment: 629
Study Start Date: November 13, 2015
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: May 9, 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Blinded Phase: B/F/TAF
B/F/TAF + ABC/DTG/3TC placebo for at least 96 weeks
Drug: B/F/TAF

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

Other Name: GS-9883/F/TAF
Drug: ABC/DTG/3TC Placebo

Tablets administered orally, once daily, without regard to food

Active Comparator: Blinded Phase: ABC/DTG/3TC
ABC/DTG/3TC + B/F/TAF placebo for at least 96 weeks
Drug: ABC/DTG/3TC

600/50/300 mg tablets administered orally, once daily, without regard to food

Other Name: Triumeq®
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 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 naïve (≤ 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 ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula
  • Negative screening test for HLA-B*5701 allele provided by Gilead Sciences

  • Key

Exclusion Criteria:
  • An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to study protocol)
  • Decompensated cirrhosis (e.g, 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
  • Chronic Hepatitis B Virus (HBV) infection
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: NCT02607930

Locations

United States, Alabama
Birmingham, Alabama, United States, 35294-2050
United States, Arizona
Phoenix, Arizona, United States, 85012
Phoenix, Arizona, United States, 85015
United States, California
Los Angeles, California, United States, 90027
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90069
Newport Beach, California, United States, 92663
Oakland, California, United States, 94602
Sacramento, California, United States, 95825
San Diego, California, United States, 92103
San Francisco, California, United States, 94118
San Leandro, California, United States, 94577
Torrance, California, United States, 90502
United States, Colorado
Denver, Colorado, United States, 80209
United States, District of Columbia
Washington, D.C., District of Columbia, United States, 20009
Washington, D.C., District of Columbia, United States, 20017
Washington, D.C., District of Columbia, United States, 20036
Washington, D.C., District of Columbia, United States, 20037
United States, Florida
Fort Lauderdale, Florida, United States, 33305
Fort Lauderdale, Florida, United States, 33316
Fort Pierce, Florida, United States, 34982
Miami, Florida, United States, 33133
Miami, Florida, United States
Orlando, Florida, United States, 32803
Pensacola, Florida, United States, 32504
Tampa, Florida, United States, 33614
Vero Beach, Florida, United States, 32960
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta, Georgia, United States, 30308
Atlanta, Georgia, United States, 30309
Atlanta, Georgia, United States, 30312
Augusta, Georgia, United States, 30912
Decatur, Georgia, United States, 30033
Savannah, Georgia, United States, 31401
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Springfield, Massachusetts, United States, 01199
United States, Michigan
Berkley, Michigan, United States, 48072
Detroit, Michigan, United States, 48202
United States, Minnesota
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Kansas City, Missouri, United States, 64111
Saint Louis, Missouri, United States, 63108
Saint Louis, Missouri, United States, 63110
Saint Louis, Missouri, United States, 63139
United States, New Jersey
Newark, New Jersey, United States, 07102
Somers Point, New Jersey, United States, 08244
United States, New Mexico
Santa Fe, New Mexico, United States, 87505
United States, New York
Albany, New York, United States, 12208
Buffalo, New York, United States, 14215
Manhasset, New York, United States, 11030
The Bronx, New York, United States, 10457
The Bronx, New York, United States, 10467-2490
United States, North Carolina
Chapel Hill, North Carolina, United States, 27514
Charlotte, North Carolina, United States, 28209
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, 27157-1042
United States, Ohio
Akron, Ohio, United States, 44304
Cincinnati, Ohio, United States, 45267
Cleveland, Ohio, United States, 44109
Columbus, Ohio, United States, 43210
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, 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, Washington
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99204
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Belgium
Brussels, Belgium, 1200
Ghent, Belgium, B-9000
Canada
Montreal, Canada, H2L 5B1
Montreal, Canada, H2X 2P4
Montreal, Canada, H3H 1V1
Ottawa, Canada, K1H 8L6
Toronto, Canada, M4N 3M5
Toronto, Canada, M5G 1K2
Vancouver, Canada, V6Z 2T1
Winnipeg, Canada, R3A 1R9
Dominican Republic
Santo Domingo, Dominican Republic
France
Lyon cedex 04, France, 69317
Nice, France, 6200
PARIS cedex 10, France, 75010
Paris cedex 12, France, 75571
Tourcoing, France, 59208
Germany
Berlin, Germany, 13353
Bonn, Germany, 53127
Hamburg, Germany, 20146
Italy
Bergamo, Italy, 24127
Milano, Italy, 20127
Roma, Italy
Puerto Rico
San Juan, Puerto Rico, 00909
San Juan, Puerto Rico, 00936-5067
San Juan, Puerto Rico, 935
Spain
Badalona, Barcelona, Spain, 8916
Alicante, Spain, 3010
Badalona, Spain, 8907
Barcelona, Spain, 8036
Cordoba, Spain, 14004
Madrid, Spain, 28034
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28046
Vigo, Spain, 36312
United Kingdom
Birmingham, United Kingdom, B4 6DH
Brighton, United Kingdom, BN2 3EW
London, United Kingdom, E1 1BB
London, United Kingdom, NW3 2QG
London, United Kingdom, SE5 9RJ
London, United Kingdom, SW10 9TH
London, United Kingdom, WC1E 6JB
Manchester, United Kingdom, M8 5RB

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director Gilead Sciences
More Information

More Information


Responsible Party: Gilead Sciences  
ClinicalTrials.gov Identifier: NCT02607930   History of Changes  
Other Study ID Numbers: GS-US-380-1489  
  2015-004024-54  
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
Lamivudine
Emtricitabine
Abacavir
Dolutegravir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.