- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03797014
B/F/TAF Switch Study for HIV-HBV Coinfection (BEST-HBV)
October 31, 2023 updated by: Joel Chua, University of Maryland, Baltimore
Efficacy, Safety, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-HBV Coinfection
The primary objective of this study is to evaluate the efficacy and safety of fixed dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults coinfected with both HIV-1 and hepatitis B. As this is a switch study, all eligible subjects enrolled will be switched from their current antiretroviral regimen to B/F/TAF will be followed on treatment for 48 weeks.
Study Overview
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- Institute of Human Virology Clinical Research Unit
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19114
- Newlands Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 years or older at enrollment.
- Documented HIV-1 infection and currently on a stable regimen for at least 3 months if on an INSTI-based regimen (6 months if on a non-INSTI-based regimen) preceding the screening visit with documented plasma HIV-1 RNA ≤ 50 copies/mL for at least 3 months preceding the screening visit.
- No known history of resistance to tenofovir alafenamide (TAF), emtricitabine (FTC), or Bictegravir (BIC).
- Documented chronic hepatitis B infection, based on any of the following: a. Positive HBsAg result or nucleic acid test for HBV DNA (including qualitative, quantitative, and genotype testing) or positive HBeAg on two occasions at least 6 months apart (any combination of these tests performed 6 months apart is acceptable); or b. Negative immunoglobulin M (IgM) antibodies to HBV core antigen (anti-HBc IgM) AND a positive results on one of the following tests: HBsAg, HBeAg, or nucleic acid test for HBV DNA (including qualitative, quantitative, and genotype testing) prior to or at screening.
- No current or prior regimen containing three active anti-HBV agents (i.e. cannot be on tenofovir alafenamide (TDF)/emtricitabine (FTC)/entecavir or TDF/lamivudine (3TC)/entecavir).
- Must have a primary care provider(s) for medical management.
- Females of childbearing potential must agree to utilize protocol recommended highly effective contraceptive methods or be non-heterosexually active or practice sexual abstinence from screening and throughout the duration of the study. Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least 3 months prior to study drug dosing.
- Male subjects must be willing to abstain from heterosexual intercourse or use a condom throughout the study period.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Written informed consent must be obtained before any study procedure is performed.
Exclusion Criteria:
- Females who are pregnant or breastfeeding.
- Any known allergies to any of the components of B/F/TAF.
- Treatment with another investigational drug within three months of enrollment.
Abnormal hematological and biochemical parameters at screening, including:
- Absolute neutrophil count (ANC) < 750 cells/mm3.
- Platelets < 50,000/mm3.
- Hemoglobin < 8.5 g/dL.
- AST or ALT of > 5 times upper limit of normal (ULN).
- Estimated GFR < 30 mL/min/1.73 m2.
- Total bilirubin > 1.5 times ULN.
- Previous or current history of malignancy, other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma. Note: Those with a history of malignancy who are in remission for two or more years may be included in the study.
- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening.
- Subjects experiencing decompensated cirrhosis (e.g. ascites, encephalopathy, or variceal bleeding).
- Acute hepatitis in the 30 days prior to study entry.
- Active tuberculosis infection.
- Subjects receiving ongoing therapy with any medications contraindicated for co-administration with B/F/TAF FDC, including but not limited to the following medications: dofetilide, phenobarbital, phenytoin, carbamazepine, oxcarbamazepine, rifampin, rifapentine, cisapride, St. John's Wort, and Echinaceae.
- Current alcohol or substance use that in the opinion of the investigator may interfere with subject study compliance.
- Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study or unable to comply with the dosing requirements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: B/F/TAF
Treatment group (1-arm study)
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Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV-1 RNA at Week 24
Time Frame: Week 24
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Proportion of participants with HIV-1 RNA <50 copies/mL at Week 24 by US FDA Snapshot Algorithm
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Week 24
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HBV DNA at Week 24
Time Frame: Week 24
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Proportion of participants with plasma HBV DNA <29 IU/mL at Week 24 as defined by Missing=Failure Approach
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Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV-1 RNA at Week 48
Time Frame: Week 48
|
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 by US FDA Snapshot Algorithm
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Week 48
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HBV DNA at Week 48
Time Frame: Week 48
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Proportion of participants with plasma HBV DNA <29 IU/mL at Week 48 as defined by Missing=Failure Approach
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Week 48
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CD4 Cell Count Change at Week 24
Time Frame: Baseline; Week 24
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Change from baseline in CD4 cell count at Week 24
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Baseline; Week 24
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CD4 Cell Count Change at Week 48
Time Frame: Baseline; Week 48
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Change from baseline in CD4 cell count at Week 48
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Baseline; Week 48
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ALT Normalization at Week 24
Time Frame: Week 24
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Proportion of participants with normal ALT at Week 24
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Week 24
|
ALT Normalization at Week 48
Time Frame: Week 48
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Proportion of participants with normal ALT at Week 48
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Week 48
|
HBeAg Loss at Week 48
Time Frame: Week 48
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Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit.
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Week 48
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HBsAg Loss at Week 48
Time Frame: Week 48
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Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit.
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Week 48
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joel V Chua, MD, Institute of Human Virology, University of Maryland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2019
Primary Completion (Actual)
November 22, 2022
Study Completion (Actual)
May 5, 2023
Study Registration Dates
First Submitted
January 4, 2019
First Submitted That Met QC Criteria
January 7, 2019
First Posted (Actual)
January 8, 2019
Study Record Updates
Last Update Posted (Estimated)
November 3, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Hepatitis B
- Hepatitis
- Coinfection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Emtricitabine
- Emtricitabine tenofovir alafenamide
Other Study ID Numbers
- HP00083844
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data is available upon reasonable request from the investigator.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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