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Clinical Trials

MainTitle

Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

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


Information provided by (Responsible Party)
Gilead Sciences
ClinicalTrials.gov Identifier
NCT02603107

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

Purpose

This study will evaluate the safety and efficacy of switching to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.

Condition Intervention Phase
HIV-1 Infection

Drug : RTV
Drug : ATV
Drug : DRV
Drug : COBI
Drug : ATV/co
Drug : DRV/co
Drug : FTC/TDF
Drug : ABC/3TC
Drug : B/F/TAF
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

Further study details as provided by Gilead Sciences:

Primary Outcome Measures

  • Proportion of participants with 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 with HIV-1 RNA < 50 copies/mL at Week 48 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 ]

Estimated Enrollment: 520
Study Start Date: November 20, 2015
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: May 15, 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: B/F/TAF
Participants will switch to B/F/TAF FDC and continue treatment for 48 weeks, and participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 96 additional weeks.
Drug: B/F/TAF

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

Experimental: Current antiretroviral regimen
Participants will remain on current antiretroviral regimen consisting of ritonavir boosted ATV (RTV+ATV), ritonavir boosted DRV (RTV+DRV), cobicistat boosted ATV (COBI+ATV or ATV/co), or cobicistat boosted DRV (COBI+DRV or DRV/co) plus either FTC/TDF or ABC/3TC for 48 weeks. Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 96 additional weeks.
Drug: RTV

100 mg capsule coadministered orally with ATV or DRV once daily with food

Drug: ATV

300 mg capsule administered orally once daily with food

Drug: DRV

800 mg tablet administered orally once daily with food

Drug: COBI

150 mg tablet coadministered orally with ATV or DRV once daily with food

Other Name:
  • Tybost®
  • GS-9350

Drug: ATV/co

300/150 mg FDC tablet administered orally once daily with food

Other Name: Evotaz
Drug: DRV/co

800/150 mg FDC tablet administered orally once daily with food

Other Name: Prezcobix
Drug: FTC/TDF

200/300 mg FDC tablet administered orally once daily without regard to food

Other Name: Truvada®
Drug: ABC/3TC

600/300 mg tablet administered orally once daily with or without regard to food

Drug: B/F/TAF

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

Eligibility

Eligibility

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

Criteria

Key Inclusion Criteria:

  • Currently receiving a once daily antiretroviral regimen consisting of ritonavir or cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC for ≥ 6 months preceding the screening visit
  • Adequate renal function:
    • Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft Gault formula
  • Life expectancy ≥ 1 year
  • Currently on a stable regimen for ≥ 6 months preceding the screening visit with documented plasma HIV-1 RNA < 50 copies/mL for ≥ 6 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 FTC, tenofovir, ABC or 3TC, including but not limited to the reverse transcriptase resistance mutations K65R and M184V/I
  • No previous use of any approved or experimental integrase strand transfer inhibitor (INSTI)

  • Key

Exclusion Criteria:
  • An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
  • Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
  • Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine based therapies)
  • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
  • A history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Individuals with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study
  • Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
  • Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with the dosing requirements
  • Any known allergies to the excipients of B/F/TAF FDC or ATV, RTV, DRV, COBI, FTC/TDF or ABC/3TC
  • Females who are pregnant (as confirmed by positive serum pregnancy test)
  • Females who are breastfeeding
  • Acute hepatitis in the 30 days prior to study entry
  • Chronic hepatitis B infection in individuals not on a TDF containing regimen, as determined by either:
    • Positive hepatitis B virus (HBV) surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit
    • Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit
  • Active tuberculosis 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: NCT02603107

Locations

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, 94102
San Leandro, California, United States, 94577
Torrance, California, United States, 90502
United States, Colorado
Aurora, Colorado, United States, 80045
United States, District of Columbia
Washington, D.C., District of Columbia, United States, 20017
Washington, D.C., District of Columbia, United States, 20036
United States, Florida
DeLand, Florida, United States, 32720
Fort Lauderdale, Florida, United States, 33316
Fort Pierce, Florida, United States, 34982
Miami, Florida, United States, 33133
Miami, Florida, United States, 33136
Orlando, Florida, United States, 32803-1851
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
Atlanta, Georgia, United States, 30312
Augusta, Georgia, United States, 30912
Macon, Georgia, United States, 31201
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Chicago, Illinois, United States, 60613
Chicago, Illinois, United States, 60657
Chicago, Illinois, United States
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Boston, Massachusetts, United States, 01211
Springfield, Massachusetts, United States, 1105
United States, Michigan
Berkley, Michigan, United States, 48072
United States, Minnesota
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Kansas City, Missouri, United States, 64111
Saint Louis, Missouri, United States, 63139
United States, New York
Buffalo, New York, United States, 14215
The Bronx, New York, United States, 10467
The Bronx, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7080
Charlotte, North Carolina, United States, 28209
Durham, North Carolina, United States, 27710
Greenville, North Carolina, United States, 27834
Huntersville, North Carolina, United States, 28078
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Columbia, South Carolina, United States, 29203
United States, Tennessee
Memphis, Tennessee, United States, 38105
United States, Texas
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75215
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, Virginia
Annandale, Virginia, United States, 22003-7313
United States, Washington
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99204
Australia
Darlinghurst, New South Wales, Australia, 2010
Sydney, New South Wales, Australia, 2010
Melbourne, Victoria, Australia, 3004
Prahran, Victoria, Australia, 3141
Victoria, Australia, 3068
Belgium
Brussels, Belgium, 1000
Ghent, Belgium, 9000
Canada
Vancouver, British Columbia, Canada, V6Z 2T1
Toronto, Ontario, Canada, M5G 1K2
Toronto, Ontario, Canada, M5G2N2
Montreal, Quebec, Canada, H2L 4P9
Montreal, Quebec, Canada, H3A 1T1
Montreal, Quebec, Canada, H4A 3J1
Dominican Republic
Santo Domingo, Dominican Republic
France
Lyon, France, 69317
Nantes, France, 44093
Nice, France, 6202
Paris, France, 75010
Paris, France, 75571
Tourcoing, France, 59200
Tours, France, 37000
Germany
Düsseldorf, Nordrhein-Westfalen, Germany, 40237
Berlin, Germany, 12157
Berlin, Germany, 13353
Bonn, Germany, 53127
Essen, Germany, 45122
Frankfurt, Germany, 60590
Frankfurt, Germany, 60596
Hamburg, Germany, 20251
Köln, Germany, 50924
Munchen, Germany, 81675
München, Germany, 80335
Italy
Milano, Italy, 20127
Milano, Italy, 20157
Roma, Italy, 00149
Puerto Rico
Ponce, Puerto Rico, 00731
Rio Piedras, Puerto Rico, 935
San Juan, Puerto Rico, 00909
San Juan, Puerto Rico, 00935
Spain
Madrid, Spain, 28034
Madrid, Spain, 28040
Málaga, Spain, 29010
United Kingdom
Birmingham, United Kingdom, B4 6DH
Brighton, United Kingdom, BN2 3EW
Edinburgh, United Kingdom, EH4 2XU
London, United Kingdom, E1 1BB
London, United Kingdom, NW3 2QG
London, United Kingdom, SE1 7EH
London, United Kingdom, SE5 9RJ
London, United Kingdom, SW10 9TH
London, United Kingdom, SW17 0QT
London, United Kingdom, W2 1NY
Manchester, United Kingdom, M13 0FH
Manchester, United Kingdom, M8 5RB
Merseyside, United Kingdom, L7 8XP
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: NCT02603107   History of Changes  
Other Study ID Numbers: GS-US-380-1878  
  2015-004011-20  
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  

Additional relevant MeSH terms:
Tenofovir
Lamivudine
Emtricitabine
Darunavir
Atazanavir Sulfate
Abacavir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

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