Clinical Trials

MainTitle

Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed

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


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02603120

First received: November 10, 2015
Last updated: November 17, 2017
Last Verified: November 2017
History of Changes
Purpose

Purpose

This study will evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed HIV-1 infected 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 Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Proportion of participants with virologic failure (HIV-1 RNA ≥ 50 copies/mL) as defined by the modified US FDA-defined snapshot algorithm [ Time Frame: Week 48 ]
Secondary Outcome Measures:
  • Proportion of participants with HIV-1 RNA < 50 copies/mL as defined by the US FDA-defined snapshot algorithm [ Time Frame: Week 48 ]
  • Change from baseline in CD4+ cell count at Week 48 [ Time Frame: Baseline and Week 48 ]
  • Percentage change from baseline in hip and spine bone mineral density (BMD) at Week 48 [ Time Frame: Baseline and Week 48 ]

Enrollment: 567
Study Start Date: November 11, 2015
Estimated Study Completion Date: July 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 48 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: 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 48 weeks
Drug: ABC/DTG/3TC

600/50/300 mg FDC 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 96 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:

  • Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec)
  • Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for ≥ 3 months prior to the screening visit
  • HIV RNA < 50 copies/mL at the screening visit
  • Currently on a stable regimen for ≥ 3 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 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).
  • Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV), DTG, ABC or 3TC

  • Key

Exclusion Criteria:
  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
  • Active tuberculosis infection
  • Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
  • Females who are pregnant
  • Females who are breastfeeding
  • Acute hepatitis in the 30 days prior to study entry
  • 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: NCT02603120

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, 90033
Los Angeles, California, United States, 90036
Los Angeles, California, United States, 90069
Oakland, California, United States, 94602
Oakland, California, United States, 94609
Palm Springs, California, United States, 92264
Sacramento, California, United States, 95187
Sacramento, California, United States, 95825
San Leandro, California, United States, 94577
United States, District of Columbia
Washington, District of Columbia, United States, 20009
Washington, District of Columbia, United States, 20036
United States, Florida
DeLand, Florida, United States, 32720
Fort Lauderdale, Florida, United States, 33308
Fort Lauderdale, Florida, United States, 33316
Fort Pierce, Florida, United States, 34982
Miami Beach, Florida, United States, 33139
Miami, Florida, United States, 33133
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
Wilton Manors, Florida, United States, 33305
United States, Georgia
Augusta, Georgia, United States, 30912
Decatur, Georgia, United States, 30033
Macon, Georgia, United States, 31201
Savannah, Georgia, United States, 31401
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Chicago, Illinois, United States, 60613
Chicago, Illinois, United States, 60657
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston, Massachusetts, United States, 02118-2393
Springfield, Massachusetts, United States, 01105
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, 63139
United States, New Jersey
Newark, New Jersey, United States, 07102
United States, New Mexico
Santa Fe, New Mexico, United States, 87505
United States, New York
Bronx, New York, United States, 10467-2490
Buffalo, New York, United States, 14215
New York, New York, United States, 10011
United States, North Carolina
Charlotte, North Carolina, United States, 28207
Greenville, North Carolina, United States, 27834
Huntersville, North Carolina, United States, 28078
United States, Ohio
Cincinnati, Ohio, United States, 45267-0560
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Columbia, South Carolina, United States, 29203-6840
United States, Texas
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75219
Dallas, Texas, United States, 75246
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
Australia
Sydney, New South Wales, Australia, 2010 NSW
Sydney, New South Wales, Australia, 2010
Belgium
Ghent, Belgium, 9000
Canada
Vancouver, British Columbia, Canada, V6Z 2T1
Winnipeg, Manitoba, Canada, R3A 1R9
Montreal, Quebec, Canada, H2L 4P9
Montreal, Quebec, Canada, H3A 1T1
Montreal, Quebec, Canada, H4A 3J1
France
Nantes, France, 44093
NICE Cedex 03, France, 6202
Paris cedex 20, France, 75970
Paris, France, 75010
Germany
Berlin, Germany, 12157
Berlin, Germany, 13353
Bonn, Germany, 53127
Essen, Germany, 45122
Frankfurt am Main, Germany, 60596
Hamburg, Germany, 20146
Munich, Germany, 80336
München, Germany, 80335
Italy
Roma, Italy, 00149
Puerto Rico
San Juan, Puerto Rico, 00909-1711
San Juan, Puerto Rico, 00909
Spain
Badalona, Spain, 08916
Badalona, Spain, 8907
Barcelona, Spain, 8025
Cordoba, Spain, 14004
Madrid, Spain, 28034
Santiago de Compostela, Spain, 15706
Sevilla, Spain, 41013
United Kingdom
Brighton, United Kingdom, BN2 3EW
Manchester, United Kingdom, M13 0FH
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: NCT02603120   History of Changes  
Other Study ID Numbers: GS-US-380-1844  
  2015-004025-14  
Study First Received: November 10, 2015  
Last Updated: November 17, 2017  

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

Additional relevant MeSH terms:
Lamivudine
Dolutegravir

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.