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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 (Alliance)

Primary Purpose

HIV-1/HBV Co-Infection

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
B/F/TAF
Placebo to match DTG
Placebo to match F/TDF
DTG
F/TDF
Placebo to match B/F/TAF
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1/HBV Co-Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Midway Immunology & Research
  • Triple O Research Institute, P.A.
  • Be Well Medical Center
  • The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)
  • Beijing Ditan Hospital Capital Medical University
  • Beijing YouAn Hospital, Capital Medical University
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  • The First Hospital of Changsha
  • Chengdu Public Health Clinical Center
  • Guangzhou Eighth people's Hospital
  • 1st Affiliated Hospital of Zhejiang University
  • The Second Hospital of Nanjing
  • Shanghai Public Health Clinical Center
  • Third People's Hospital Of Shenzhen
  • Instituto Dominicano de Estudios Virologicos (IDEV)
  • Hôpital de la Croix Rousse
  • Evaggelismos General Hospital of Athens
  • Korgialenio-Benakio Greek Red Cross General Hospital
  • Laiko General Hospital
  • AHEPA University Hospital of Thessaloniki
  • Prince of Wales Hospital
  • Queen Elizabeth Hospital (QEH)
  • Princess Margaret Hospital
  • National Hospital Organization Nagoya Medical Center
  • University of the Ryukyus Hospital
  • Osaka City General Hospital
  • National Hospital Organization Osaka National Hospital
  • The Jikei University Hospital
  • Juntendo University Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • Yokohama City University Hospital
  • Pusan National University Hospital
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Hospital Raja Permaisuri Bainun
  • Hospital Raja Perempuan Zainab II
  • Queen Elizabeth Hospital
  • University Malaya Medical Centre
  • Hospital Kuala Lumpur
  • Hospital Sultanah Nur Zahirah
  • Sarawak General Hospital
  • Hospital Pulau Pinang
  • Sungai Buloh Hospital
  • Hope Clinical Research
  • Hospital Clinic de Barcelona
  • Hospital General Universitario Santa Lucia
  • Fundacion Jimenez Diaz
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital de Canarias
  • Hospital General Universitario de Valencia
  • CHUVI - Hospital Universitario Alvaro Cunqueiro
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung Veterans General Hospital
  • Far Eastern Memorial Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei City Hospital Linsen, Chinese Medicine and Kunming Branch
  • Ministry of Health and Welfare Taoyuan General Hospital
  • Thai Red Cross AIDS Research Centre (HIV-NAT)
  • Faculty of Medicine Ramathibodi Hospital, Mahidol University
  • Siriraj Hospital
  • Faculty of Medicine, Chiang Mai University
  • Chiang Rai Reginal Hospital
  • Srinagarind Hospital
  • Bamrasnaradura Infectious Diseases Institute
  • Istanbul University Cerrahpasa Medical Faculty
  • Marmara University Pendik Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

B/F/TAF

DTG+F/TDF

Open-label Extension Phase: B/F/TAF

Arm Description

B/F/TAF + placebo to match DTG + placebo to match F/TDF for 96 weeks.

DTG + F/TDF + placebo to match B/F/TAF for 96 weeks.

After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, 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 48 weeks, or until the product becomes accessible through an access program, or until Gilead elects to discontinue the study in that country, whichever occurs first.

Outcomes

Primary Outcome Measures

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm (Co-primary Endpoint)
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Percentage of Participants With Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach (Co-primary Endpoint)
This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing on-treatment data were treated as HBV DNA ≥ 29 IU/mL.

Secondary Outcome Measures

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Change From Baseline in CD4 Cell Count at Week 48
Change From Baseline in CD4 Cell Count at Week 96
Change From Baseline in CD4 Percentage at Week 48
Change From Baseline in CD4 Percentage at Week 96
Percentage of Participants With Plasma HBV DNA < 29 IU/mL at Week 96
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) Criteria
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis.
Percentage of Participants With ALT Normalization at Week 96
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis.
Percentage of Participants With HBsAg Loss at Week 96

Full Information

First Posted
May 24, 2018
Last Updated
September 26, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03547908
Brief Title
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
Acronym
Alliance
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
February 25, 2022 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1/HBV Co-Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B/F/TAF
Arm Type
Experimental
Arm Description
B/F/TAF + placebo to match DTG + placebo to match F/TDF for 96 weeks.
Arm Title
DTG+F/TDF
Arm Type
Active Comparator
Arm Description
DTG + F/TDF + placebo to match B/F/TAF for 96 weeks.
Arm Title
Open-label Extension Phase: B/F/TAF
Arm Type
Experimental
Arm Description
After Week 96, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, 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 48 weeks, or until the product becomes accessible through an access program, or until Gilead elects to discontinue the study in that country, whichever occurs first.
Intervention Type
Drug
Intervention Name(s)
B/F/TAF
Other Intervention Name(s)
Biktarvy®
Intervention Description
50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food
Intervention Type
Drug
Intervention Name(s)
Placebo to match DTG
Intervention Description
Tablet administered orally once daily, without regard to food
Intervention Type
Drug
Intervention Name(s)
Placebo to match F/TDF
Intervention Description
Tablet administered orally once daily, without regard to food
Intervention Type
Drug
Intervention Name(s)
DTG
Intervention Description
50 mg tablet administered orally once daily, without regard to food
Intervention Type
Drug
Intervention Name(s)
F/TDF
Other Intervention Name(s)
Truvada®
Intervention Description
200/300 mg tablet administered orally once daily, without regard to food
Intervention Type
Drug
Intervention Name(s)
Placebo to match B/F/TAF
Intervention Description
Tablet administered orally once daily, without regard to food
Primary Outcome Measure Information:
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm (Co-primary Endpoint)
Description
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame
Week 48
Title
Percentage of Participants With Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach (Co-primary Endpoint)
Description
This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing on-treatment data were treated as HBV DNA ≥ 29 IU/mL.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
Time Frame
Week 96
Title
Change From Baseline in CD4 Cell Count at Week 48
Time Frame
Baseline; Week 48
Title
Change From Baseline in CD4 Cell Count at Week 96
Time Frame
Baseline; Week 96
Title
Change From Baseline in CD4 Percentage at Week 48
Time Frame
Baseline; Week 48
Title
Change From Baseline in CD4 Percentage at Week 96
Time Frame
Baseline; Week 96
Title
Percentage of Participants With Plasma HBV DNA < 29 IU/mL at Week 96
Time Frame
Week 96
Title
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) Criteria
Description
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis.
Time Frame
Week 48
Title
Percentage of Participants With ALT Normalization at Week 96
Time Frame
Week 96
Title
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
Description
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis.
Time Frame
Week 48
Title
Percentage of Participants With HBsAg Loss at Week 96
Time Frame
Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Midway Immunology & Research
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Triple O Research Institute, P.A.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Be Well Medical Center
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Beijing Ditan Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
Beijing YouAn Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100069
Country
China
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The First Hospital of Changsha
City
Changsha
ZIP/Postal Code
410005
Country
China
Facility Name
Chengdu Public Health Clinical Center
City
Chengdu
ZIP/Postal Code
610066
Country
China
Facility Name
Guangzhou Eighth people's Hospital
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
1st Affiliated Hospital of Zhejiang University
City
Hangzhou
Country
China
Facility Name
The Second Hospital of Nanjing
City
Nanjing
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
ZIP/Postal Code
201058
Country
China
Facility Name
Third People's Hospital Of Shenzhen
City
Shenzhen
ZIP/Postal Code
518040
Country
China
Facility Name
Instituto Dominicano de Estudios Virologicos (IDEV)
City
Santo Domingo
ZIP/Postal Code
10103
Country
Dominican Republic
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Evaggelismos General Hospital of Athens
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Korgialenio-Benakio Greek Red Cross General Hospital
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
Laiko General Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
AHEPA University Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital (QEH)
City
Hong Kong
Country
Hong Kong
Facility Name
Princess Margaret Hospital
City
Kowloon
Country
Hong Kong
Facility Name
National Hospital Organization Nagoya Medical Center
City
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
University of the Ryukyus Hospital
City
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
The Jikei University Hospital
City
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
ZIP/Postal Code
31350
Country
Malaysia
Facility Name
Hospital Raja Perempuan Zainab II
City
Kota Bahru
ZIP/Postal Code
15580
Country
Malaysia
Facility Name
Queen Elizabeth Hospital
City
Kota Kinabalu
ZIP/Postal Code
88200
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
53000
Country
Malaysia
Facility Name
Hospital Sultanah Nur Zahirah
City
Kuala Terengganu
ZIP/Postal Code
20400
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
ZIP/Postal Code
10450
Country
Malaysia
Facility Name
Sungai Buloh Hospital
City
Sungai Buloh
ZIP/Postal Code
47000
Country
Malaysia
Facility Name
Hope Clinical Research
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Santa Lucia
City
Cartagena
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital de Canarias
City
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
CHUVI - Hospital Universitario Alvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
22060
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Taipei City Hospital Linsen, Chinese Medicine and Kunming Branch
City
Taipei
ZIP/Postal Code
10844
Country
Taiwan
Facility Name
Ministry of Health and Welfare Taoyuan General Hospital
City
Taoyuan City
ZIP/Postal Code
33004
Country
Taiwan
Facility Name
Thai Red Cross AIDS Research Centre (HIV-NAT)
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Faculty of Medicine Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Faculty of Medicine, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Chiang Rai Reginal Hospital
City
Chiang Rai
ZIP/Postal Code
57000
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Bamrasnaradura Infectious Diseases Institute
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Marmara University Pendik Training and Research Hospital
City
Istanbul
ZIP/Postal Code
81190
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Avihingsanon, A. 2022. Week 48 results of a Phase 3 randomized controlled trial of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) vs dolutegravir + emtricitabine/tenofovir Disoproxil Fumarate (DTG+F/TDF) as initial treatment in HIV/HBV-coinfected adults (ALLIANCE). AIDS, 29 July 29-2 August 2022, Montréal, Québec, Canada.
Results Reference
background
PubMed Identifier
37494942
Citation
Avihingsanon A, Lu H, Leong CL, Hung CC, Koenig E, Kiertiburanakul S, Lee MP, Supparatpinyo K, Zhang F, Rahman S, D'Antoni ML, Wang H, Hindman JT, Martin H, Baeten JM, Li T; ALLIANCE Study Team. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 and hepatitis B coinfection (ALLIANCE): a double-blind, multicentre, randomised controlled, phase 3 non-inferiority trial. Lancet HIV. 2023 Oct;10(10):e640-e652. doi: 10.1016/S2352-3018(23)00151-0. Epub 2023 Jul 23.
Results Reference
background
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-380-4458
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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