HIV-1-infectionPhase 4BEST-HBVNCT03797014

B/F/TAF Switch Study for HIV-HBV Coinfection

A Phase 4 study testing B/F/TAF in people with HIV-1-infection and Hepatitis B, run by University of Maryland, Baltimore at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1-infection, Hepatitis B
What is being tested?: B/F/TAF
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 2 sitesUnited States
Study dates: 30 Apr 2019to 5 May 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Institute of Human Virology Clinical Research Unit
Baltimore, Maryland, 21201
Newlands Health
Philadelphia, Pennsylvania, 19114

Other trials in United States

About this study

Official title: 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.

Conditions: HIV-1-infection, Hepatitis B
Being tested: B/F/TAF
Keywords: HIV-1, Hepatitis B, HIV-HBV coinfection, Bictegravir, B/F/TAF, Tenofovir alafenamide, Biktarvy
Medical subject headings: Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

B/F/TAFDrug
Also called Bictegravir/emtricitabine/tenofovir alafenamide
Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.

Study groups in NCT03797014
Study group	Role	What they receive
B/F/TAF	Experimental	Treatment group (1-arm study) Receives: Drug: B/F/TAF

What is being measured

The primary outcome is the main question the study is designed to answer.

HIV-1 RNA at Week 24
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 24 by US FDA Snapshot Algorithm
Measured: Week 24
HBV DNA at Week 24
Proportion of participants with plasma HBV DNA <29 IU/mL at Week 24 as defined by Missing=Failure Approach
Measured: Week 24

Secondary outcomes (8)

HIV-1 RNA at Week 48
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 by US FDA Snapshot Algorithm
Measured: Week 48
HBV DNA at Week 48
Proportion of participants with plasma HBV DNA <29 IU/mL at Week 48 as defined by Missing=Failure Approach
Measured: Week 48
CD4 Cell Count Change at Week 24
Change from baseline in CD4 cell count at Week 24
Measured: Baseline; Week 24
CD4 Cell Count Change at Week 48
Change from baseline in CD4 cell count at Week 48
Measured: Baseline; Week 48
ALT Normalization at Week 24
Proportion of participants with normal ALT at Week 24
Measured: Week 24
ALT Normalization at Week 48
Proportion of participants with normal ALT at Week 48
Measured: Week 48
HBeAg Loss at Week 48
Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit.
Measured: Week 48
HBsAg Loss at Week 48
Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit.
Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 20195 May 2023

First posted8 Jan 2019
Study start30 Apr 2019
Primary completion22 Nov 2022
Study completion5 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV-1-infectionStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is an open-label phase 4 switch study to evaluate the efficacy, safety, and tolerability of FDC B/F/TAF in adults with HIV-1 and HBV coinfection.
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03797014
Sponsor's protocol ID: HP00083844
Acronym: BEST-HBV
Status last verified: Oct 2023
First submitted: 4 Jan 2019
Last updated: 3 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Individual participant data is available upon reasonable request from the investigator.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy, Safety, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-HBV Coinfection
ClinicalTrials.gov ID: NCT03797014
Acronym / sponsor ID: BEST-HBV / HP00083844
Conditions: HIV-1-infection, Hepatitis B
Keywords: HIV-1, Hepatitis B, HIV-HBV coinfection, Bictegravir, B/F/TAF, Tenofovir alafenamide, Biktarvy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: Gilead Sciences
Study start: 30 Apr 2019 (actual)
Primary completion: 22 Nov 2022 (actual)
Study completion: 5 May 2023 (actual)
First posted: 8 Jan 2019 (actual)
Results: Posted 18 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is an open-label phase 4 switch study to evaluate the efficacy, safety, and tolerability of FDC B/F/TAF in adults with HIV-1 and HBV coinfection.

Arm	Type	Receives
B/F/TAF	Experimental	Drug: B/F/TAFTreatment group (1-arm study)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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).

Key exclusion criteria (18 listed)

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:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
B/F/TAFAlso: Bictegravir/emtricitabine/tenofovir alafenamideFixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.	Drug	B/F/TAF

Primary outcome

HIV-1 RNA at Week 24
Time frame: Week 24
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 24 by US FDA Snapshot Algorithm
HBV DNA at Week 24
Time frame: Week 24
Proportion of participants with plasma HBV DNA <29 IU/mL at Week 24 as defined by Missing=Failure Approach

8 secondary outcomes

HIV-1 RNA at Week 48
Time frame: Week 48
HBV DNA at Week 48
Time frame: Week 48
CD4 Cell Count Change at Week 24
Time frame: Baseline; Week 24
CD4 Cell Count Change at Week 48
Time frame: Baseline; Week 48
ALT Normalization at Week 24
Time frame: Week 24
ALT Normalization at Week 48
Time frame: Week 48
HBeAg Loss at Week 48
Time frame: Week 48
HBsAg Loss at Week 48
Time frame: Week 48

Results and safety

Results posted to the registry on 18 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
B/F/TAF	28	25

Primary outcome: HIV-1 RNA at Week 24

Time frame: Week 24. Count of participants. Unit: Participants

Measure	B/F/TAF n = 28
Value	25

Population analysed: Intention-to-Treat (ITT) population: Enrolled subjects who received at least one study drug.

Primary outcome: HBV DNA at Week 24

Time frame: Week 24. Count of participants. Unit: Participants

Measure	B/F/TAF n = 28
Value	24

Population analysed: Intention-to-Treat Population: All enrolled subjects who received at least one study drug.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the entire study participation (48 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
B/F/TAF	0 of 28 (0%)	16 of 28 (57.1%)	0 of 28

Limitations and caveats (from the sponsor): This study did not achieve its enrollment target of 60 and was adversely affected by COVID-19 pandemic travel and research restrictions particularly during April 2020 to August 2020.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Individual participant data is available upon reasonable request from the investigator.

Related trials for HIV-1-infection

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Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joel V Chua, MD principal investigator

Institute of Human Virology, University of Maryland

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing B/F/TAF in people with HIV-1-infection and Hepatitis B, run by University of Maryland, Baltimore at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV-1 RNA at Week 24 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03797014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.