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B/F/TAF Switch Study for HIV-HBV Coinfection | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

Efficacy, Safety, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-HBV Coinfection

NCT03797014•University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 years or older at enrollment.
•2. 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.
•3. No known history of resistance to tenofovir alafenamide (TAF), emtricitabine (FTC), or Bictegravir (BIC).
•4. 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.
•5. 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).
•6. Must have a primary care provider(s) for medical management.
•7. 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.
•8. Male subjects must be willing to abstain from heterosexual intercourse or use a condom throughout the study period.
•9. Stated willingness to comply with all study procedures and availability for the duration of the study.
•10. Written informed consent must be obtained before any study procedure is performed.

Exclusion Criteria

•1. Females who are pregnant or breastfeeding.
•2. Any known allergies to any of the components of B/F/TAF.
•3. Treatment with another investigational drug within three months of enrollment.
•4. Abnormal hematological and biochemical parameters at screening, including:
•1. Absolute neutrophil count (ANC) \< 750 cells/mm3.
•2. Platelets \< 50,000/mm3.
•3. Hemoglobin \< 8.5 g/dL.
•4. AST or ALT of \> 5 times upper limit of normal (ULN).
•5. Estimated GFR \< 30 mL/min/1.73 m2.
•6. Total bilirubin \> 1.5 times ULN.
+8 more criteria

Locations (2)

Institute of Human Virology Clinical Research Unit

Baltimore, Maryland, United States

Newlands Health

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 30, 2019

Primary Completion Date

November 22, 2022

Completion Date

May 5, 2023

Last Updated

November 3, 2023

Enrollment

ACTUAL participants

Conditions

HIV-1-infectionHepatitis B

Interventions

B/F/TAF

DRUG

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

NCT07024641

Hepatitis B Virus Infection

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RECRUITINGPHASE1

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

NCT07055451

HIV-1-infection

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

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