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Alliance: Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults

Sponsor
Gilead Sciences (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03547908
Collaborator
(none)
244
Enrollment
67
Locations
2
Arms
68.1
Anticipated Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG)

  • emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV and hepatitis B virus (HBV) treatment naive, HIV-1 and HBV co-infected adults.
Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
244 participants
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 Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults
Actual Study Start Date :
May 30, 2018
Actual Primary Completion Date :
Feb 25, 2022
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: B/F/TAF

B/F/TAF + placebo to match DTG + placebo to match F/TDF

Drug: B/F/TAF
50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food
Other Names:
  • Biktarvy®

    • Drug: Placebo to match DTG
    Tablet administered orally once daily, without regard to food

    Drug: Placebo to match F/TDF
    Tablet administered orally once daily, without regard to food
    Experimental: DTG+F/TDF

    DTG + F/TDF + placebo to match B/F/TAF

    Drug: DTG
    50 mg tablet administered orally once daily, without regard to food

    Drug: F/TDF
    200/300 mg tablet administered orally once daily, without regard to food
    Other Names:
  • Truvada®

    • Drug: Placebo to match B/F/TAF
    Tablet administered orally once daily, without regard to food

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [Week 48]

    2. Proportion of Participants With Plasma HBV DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach [Week 48]

    Secondary Outcome Measures

    1. Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [Week 96]

    2. Change from Baseline in CD4 Cell Count at Week 48 [Baseline; Week 48]

    3. Change from Baseline in CD4 Cell Count at Week 96 [Baseline; Week 96]

    4. Change from Baseline in CD4 Percentage at Week 48 [Baseline; Week 48]

    5. Change from Baseline in CD4 Percentage at Week 96 [Baseline; Week 96]

    6. Proportion of Participants With Plasma HBV DNA < 29 IU/mL at Week 96 [Week 96]

    7. Proportion of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 [Week 48]

    8. Proportion of Participants With ALT Normalization at Week 96 [Week 96]

    9. Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 [Week 48]

    10. Proportion of Participants With HBsAg Loss at Week 96 [Week 96]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • HIV-1 co-infection:

    • Must be HIV antiretroviral treatment naive with plasma HIV-1 RNA ≥ 500 copies/mL at screening

    • ≤ 10 days of prior therapy with any antiretroviral agent, including lamivudine and entecavir, 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)

    • Screening genotype report must show sensitivity to emtricitabine (FTC) and tenofovir (TFV). This report will be provided by Gilead Sciences. Alternatively, if genotype results from a local laboratory obtained ≤ 90 days prior to screening visit date show sensitivity to these drugs, this genotype will be acceptable to fulfill this inclusion criterion in the event that the genotype obtained at screening is not yet available and all other inclusion/exclusion criteria have been confirmed

    • HBV co-infection:

    • Must be HBV treatment naive (defined as < 12 weeks of oral antiviral treatment)

    • Screening HBV DNA ≥ 2000 IU/mL

    • Hepatic transaminases (aspartate aminotransferase (AST) and ALT) ≤ 10 x upper limit of normal (ULN)

    • Total bilirubin ≤ 2.5 x ULN

    Key Exclusion Criteria:

    • Hepatitis C virus (HCV) antibody positive and HCV RNA detectable

    • Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment

    • Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance

    • Active, serious infections (other than HIV-1 and HBV 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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Midway Immunology & Research Fort Pierce Florida United States 34982
    2 Triple O Research Institute, P.A. West Palm Beach Florida United States 33401
    3 Be Well Medical Center Berkley Michigan United States 48072
    4 The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA) Houston Texas United States 77098
    5 Beijing Ditan Hospital Capital Medical University Beijing China 100015
    6 The Fifth Medical Center of PLA General Hospital Beijing China 100045
    7 Beijing YouAn Hospital, Capital Medical University Beijing China 100069
    8 Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing China 100730
    9 The First Hospital of Changsha Changsha China 410005
    10 Chengdu Public Health Clinical Center Chengdu China 610066
    11 Guangzhou Eighth people's Hospital Guangzhou China 510060
    12 1st Affiliated Hospital of Zhejiang University Hangzhou China
    13 The Second Hospital of Nanjing Nanjing China
    14 Shanghai Public Health Clinical Center Shanghai China 201058
    15 Third People's Hospital Of Shenzhen Shenzhen China 518040
    16 Instituto Dominicano de Estudios Virologicos (IDEV) Santo Domingo Dominican Republic 10103
    17 Hôpital de la Croix Rousse Lyon France 69004
    18 Korgialenio-Benakio Greek Red Cross General Hospital Athens Greece 11526
    19 Laiko General Hospital Athens Greece 11527
    20 AHEPA University Hospital of Thessaloniki Thessaloníki Greece 546 36
    21 Queen Elizabeth Hospital (QEH) Hong Kong Hong Kong
    22 Princess Margaret Hospital Kowloon Hong Kong
    23 National Hospital Organization Nagoya Medical Center Aichi Japan 460-0001
    24 University of the Ryukyus Hospital Okinawa Japan 903-0215
    25 Osaka City General Hospital Osaka Japan 534-0021
    26 National Hospital Organization Osaka National Hospital Osaka Japan 540-0006
    27 The Jikei University Hospital Tokyo Japan 105-8471
    28 Juntendo University Hospital Tokyo Japan 113-8431
    29 Center Hospital of the National Center for Global Health and Medicine Tokyo Japan 162-8655
    30 Yokohama City University Hospital Yokohama Japan 236-0004
    31 Pusan National University Hospital Busan Korea, Republic of 49241
    32 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 6591
    33 Hospital Raja Permaisuri Bainun Ipoh Malaysia 31350
    34 Hospital Raja Perempuan Zainab II Kota Bahru Malaysia 15580
    35 Queen Elizabeth Hospital Kota Kinabalu Malaysia 88200
    36 University Malaya Medical Centre Kuala Lumpur Malaysia 50603
    37 Hospital Kuala Lumpur Kuala Lumpur Malaysia 53000
    38 Hospital Sultanah Nur Zahirah Kuala Terengganu Malaysia 20400
    39 Sarawak General Hospital Kuching Malaysia 93586
    40 Hospital Pulau Pinang Pulau Pinang Malaysia 10450
    41 Sungai Buloh Hospital Sungai Buloh Malaysia 47000
    42 Hope Clinical Research San Juan Puerto Rico 00909
    43 CHUVI - Hospital Universitario Alvaro Cunqueiro Vigo Pontevedra Spain 36312
    44 Hospital Clinic de Barcelona Barcelona Spain 08036
    45 Hospital General Universitario Santa Lucia Cartagena Spain
    46 Fundacion Jimenez Diaz Madrid Spain 28040
    47 Hospital Universitario La Paz Madrid Spain 28046
    48 Hospital de Canarias Santa Cruz De Tenerife Spain 38320
    49 Hospital General Universitario de Valencia Valencia Spain 46014
    50 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 80756
    51 Kaohsiung Veterans General Hospital Kaohsiung Taiwan 81362
    52 Far Eastern Memorial Hospital New Taipei City Taiwan 22060
    53 Taichung Veterans General Hospital Taichung Taiwan 40705
    54 National Cheng Kung University Hospital Tainan Taiwan 70403
    55 Taipei Veterans General Hospital Taipei city Taiwan 11217
    56 National Taiwan University Hospital Taipei Taiwan 10048
    57 Taipei City Hospital Linsen, Chinese Medicine and Kunming Branch Taipei Taiwan 10844
    58 Ministry of Health and Welfare Taoyuan General Hospital Taoyuan City Taiwan 33004
    59 Thai Red Cross AIDS Research Centre (HIV-NAT) Bangkok Thailand 10330
    60 Faculty of Medicine Ramathibodi Hospital, Mahidol University Bangkok Thailand 10400
    61 Siriraj Hospital Bangkok Thailand 10700
    62 Faculty of Medicine, Chiang Mai University Chiang Mai Thailand 50200
    63 Chiang Rai Reginal Hospital Chiang Rai Thailand 57000
    64 Srinagarind Hospital Khon Kaen Thailand 40002
    65 Bamrasnaradura Infectious Diseases Institute Nonthaburi Thailand 11000
    66 Istanbul University Cerrahpasa Medical Faculty Istanbul Turkey 34098
    67 Marmara University Pendik Training and Research Hospital Istanbul Turkey 81190

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT03547908
    Other Study ID Numbers:
    • GS-US-380-4458
    • 2018-000926-79
    First Posted:
    Jun 6, 2018
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis B
    Coinfection
    Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

    Study Results

    No Results Posted as of Mar 14, 2022