Clinical Trials List
2019-09-11 - 2023-07-06
Phase III
Recruiting6
Terminated3
ICD-10B20
Human immunodeficiency virus [HIV] disease
ICD-10B18.9
Chronic viral hepatitis, unspecified
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
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
Gilead Sciences
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 李佳雯 Division of Infectious Disease
- 李明吉 Division of Infectious Disease
- Po-Lin Chen Division of Infectious Disease
- Nan-Yao Lee Division of Infectious Disease
- 薛伶珊 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- CHIEN-YU CHENG Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王永衛 Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- HSIN-YUN SUN Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yen-Hsu Chen Division of Infectious Disease
- Chun-Yuan Lee Division of Infectious Disease
- 林蔚如 Division of Infectious Disease
- Jih-Jin Tsai Division of Infectious Disease
- Shang-Yi Lin Division of Infectious Disease
- 張雅婷 Division of Infectious Disease
- Chung-Hao Huang Division of Infectious Disease
- Tun-Chieh Chen Division of Infectious Disease
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The proportion of subjects that have HIV-1 RNA <50 copies/mL at Week 48 as defined by the US FDA-defined snapshot algorithm
The proportion of subjects with plasma HBV DNA < 29IU/mL at Week 48 by Missing = Failure approach
The secondaryanti-HIV efficacy endpoints are:
The proportion of subjects that have HIV-1 RNA < 50 copies/mL at Week 96
The change from baseline in CD4 cell count and CD4% at Weeks 48 and 96
The secondary anti-HBV efficacy endpoints are:
The proportion of subjects with plasma HBV DNA < 29 IU/mL at Week96
The proportion of subjects with ALT normalization atWeeks 48 and 96
The proportion of subjects with HBsAg loss at Weeks 48 and96
Inclution Criteria
1) The abilityto understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
2) Age>=18 years
3) HIV- 1 co-infection:
a) Must be HIV antiretroviral treatment naive with plasma HIV-1RNA500 copies/mL at screening
b) ≤ 10 days of prior therapy with any antiretroviral agent, including lamivudine and entecavir, following a diagnosis of HIV-1 infection (except the use for PrEP or PEP, up to one month prior to screening)
c) Screening genotype report must show sensitivity to FTC and TFV. This report will be provided by Gilead Sciences. Alternatively, if genotype results from a local laboratoryobtained ≤ 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
4) HBV co-infection:
a) Must be HBV treatment naïve (defined as < 12 weeks of oral antiviral treatment)
b) Screening HBV DNA ≥ 2000IU/mL
5) Normal ECG (or if abnormal, determined by the investigator not to be clinically significant)
6) Estimated glomerular filtration rate (eGFR) 50 mL/min according to the Cockcroft-Gault (C-G) formula
7) Hepatic transaminases (AST and ALT) 10upper limit of normal (ULN)
8) Total bilirubin 2.5upper limit of normal (ULN)
9) Adequate hematologic function (absolute neutrophil count ≥750/mm3 (≥ 0.75 GI/L); platelets ≥ 50,000/mm3 (≥ 50 GI/L); hemoglobin ≥ 8.5 g/dL (≥ 85 g/L))
10)Serum amylase ≤ 5 × ULN (subjects with serum amylase > 5× ULN will remain eligible if serum lipase is ≤ 5 ×ULN)
11)Female subjects of childbearing potential and male subjects who are fertilewho engage in heterosexual intercourse must agree to utilize protocol specified method(s) of contraception as described in Appendix6.
12)Male subjects must agree to refrain from sperm donation from first study drug dose until at least 90 days following the last study drug dose
Exclusion Criteria
1) Hepatitis C Virus (HCV) antibody positive and HCV RNA detectable
2) P revious use of any approved or experimental HIV integrase inhibitor
3) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30days prior to screening (refer toAppendix7)
4) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy,or variceal bleeding)or with Child-Pugh-Turcotte (CPT) C impairment
5) Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or ongoing systemic steroids during the study (e.g. , corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
6) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
7) Malignancy within 5 years of screening other than cutaneous Kaposi’s sarcoma, completely resected non-melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed
8) Active, serious infections (other than HIV-1 and HBV infection) requiring parenteral antibiotic or antifungal therapy within 30days prior to Day 1
9) Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
10)Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
11)Any known allergies to the excipients of B/F/TAF FDC or DTG + F/TDFFDC tablets
12)Females who are pregnant (as confirmed by positive serum pregnancy test)
13)Females who are breastfeeding
14)Subjects receiving ongoing therapy with any of the following medications in the table below, including drugs not to be used with FTC, TAF, TDF, bictegravirand DTG
15)Acute hepatitis in the 30 days prior to study entry
16)Active tuberculosis infection
The Estimated Number of Participants
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Taiwan
37 participants
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Global
240 participants
