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

NCT ID: NCT03797014

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2023-05-05

Brief 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.

Conditions

HIV-1-infection; Hepatitis B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

B/F/TAF

Treatment group (1-arm study)

Group Type: EXPERIMENTAL

B/F/TAF

Intervention Type: DRUG

Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.

Interventions

B/F/TAF

Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.

Intervention Type: DRUG

Other Intervention Names

Bictegravir/emtricitabine/tenofovir alafenamide

Eligibility Criteria

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.

5. 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.

6. An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening.

7. Subjects experiencing decompensated cirrhosis (e.g. ascites, encephalopathy, or variceal bleeding).

8. Acute hepatitis in the 30 days prior to study entry.

9. Active tuberculosis infection.

10. 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.

11. Current alcohol or substance use that in the opinion of the investigator may interfere with subject study compliance.

12. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Joel Chua

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel V Chua, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Human Virology, University of Maryland

Locations

Institute of Human Virology Clinical Research Unit

Baltimore, Maryland, United States

Newlands Health

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HP00083844

Identifier Type: -

Identifier Source: org_study_id