Clinical Trials

MainTitle

TAF for HIV-HBV With Renal Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2017 by University Hospital Inselspital, Berne

Sponsor
University Hospital Inselspital, Berne


Information provided by (Responsible Party)
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier
NCT03115736

First received: April 10, 2017
Last updated: July 10, 2017
Last Verified: July 2017
History of Changes
Purpose

Purpose

The investigators aim at describing changes in renal glomerular and tubular function with after the switch from TDF to TAF in HIV/HBV-coinfected patients with mild to moderate renal dysfunction and to assess the virological efficacy of TAF on HBV infection.

The study will include HIV/HBV-coinfected participants of the Swiss HIV Cohort Study (SHCS) who are under active care and have been on a stable, TDF-containing ART regimen for at least 6 months. Only patients with an estimated glomerular filtration rate (GFR) between 30 ml/min and 90 ml/min will be included. All individuals who agree to participate will be switched from a TDF-containing ART regimen to a TAF-containing triple ART regimen at week 0 and will be followed for 48 weeks after the treatment change.

Condition Intervention Phase
HIV and Hepatitis B Coinfection

Drug : Tenofovir Alafenamide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Cohort Study to Assess the Safety and Efficacy of Replacing Tenofovir Disoproxil Fumarate by Tenofovir Alafenamide in HIV/HBV-coinfected Patients With Mild or Moderate Renal Dysfunction

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures

  • Change in renal function [ Time Frame: 48 weeks ]
    Assessment of change in eGFR and tubular markers during the first year of TAF-containing ART
  • HBV suppression [ Time Frame: 48 weeks ]
    Evaluation of HBV virological suppression and HBsAg loss after 12 months of TAF
Secondary Outcome Measures:
  • Treatment interruptions [ Time Frame: 48 weeks ]
    Description of the proportion of patients with treatment changes or interruptions
  • Adverse events [ Time Frame: 48 weeks ]
    Evaluation of the proportion of patients with adverse events during therapy, including grade 2 or above transaminases elevations
  • Liver fibrosis change [ Time Frame: 48 weeks ]
    Assessment of the proportion of patients with a change in liver fibrosis stage

Estimated Enrollment: 50
Study Start Date: May 23, 2017
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Switch
Patients are switched from a TDF-containing antiretroviral therapy regimen to a TAF-containing regimen
Drug: Tenofovir Alafenamide

Patients are switched to either Genvoya (TAF/FTC/EVG/COB) or another FTC/TAF-containing ART regimen

Detailed Description:

Rationale:
Tenofovir alafenamide (TAF) has been shown to cause less renal complications than tenofovir disoproxil fumarate (TDF) while having the same virological efficacy against HIV and HBV infections. In a recent study from the USA and Japan, over 90% of HIV/HBV-coinfected individuals had a suppressed HBV viral load 48 weeks after TDF was replaced by TAF. Thus, TAF might be a valuable treatment option for HIV/HBV-coinfected individuals with TDF-toxicity, especially in the context of resistance to lamivudine and entecavir. However, the safety and efficacy of TAF has not been evaluated to date in HIV/HBV-coinfected patients with renal dysfunction.
Primary objectives:

  • To evaluate changes in glomerular and tubular renal function after switch from TDF to TAF in HIV/HBV coinfected patients with renal dysfunction
  • To assess the HBV virological efficacy of TAF in HIV/HBV coinfected patients with renal dysfunction switching from TDF to TAF.


Secondary
    objectives:
  • To assess the percentage of and reasons for treatment interruptions
  • To describe toxicity events including liver-related complications
  • To evaluate changes in liver fibrosis

Intervention:
In eligible patients willing to participate and who have signed an informed consent TDF will be replaced by TAF on day 1 of the study.
Products:
  • Tenofovir alafenamide/emtricitabine (TAF/FTC) Dose: one tbl. once per day in addition to at least one third compound OR
  • Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) Dose: one tbl. once per day

  • Study Population: eligible patients from all 7 centers of the Swiss HIV Cohort Study will be considered.

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

    • HIV/HBV-coinfection
    • Suppressed HIV-viremia (<200 cp/ml)
    • On TDF-containing ART since at least 6 months
    • eGFR > 30 ml/min and <90 ml/min
    • Written informed consent


    Exclusion Criteria:
    • Study drug considered by the treating physician not a valid option for the patient
    • Pregnancy
    • Decompensated liver cirrhosis

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03115736

    Contacts

    Contact:   Gilles Wandeler, MD MSc +41 787758533 gilles.wandeler@insel.ch
    Contact:   Andri Rauch, MD andri.rauch@insel.ch

    Locations

    Switzerland
    Inselspital Recruiting
    Bern, Be, Switzerland, 3010
    Contact: Gilles O Wandeler, MD    +41 787758533    gilles.wandeler@ispm.unibe.ch

    Sponsors and Collaborators

    University Hospital Inselspital, Berne

    Investigators

    Study Chair: Gilles Wandeler, MD MSc University Hospital Inselspital, Berne
    More Information

    More Information


    Responsible Party: University Hospital Inselspital, Berne  
    ClinicalTrials.gov Identifier: NCT03115736   History of Changes  
    Other Study ID Numbers: INSEL-HINF-2017-1  
    Study First Received: April 10, 2017  
    Last Updated: July 10, 2017  

    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.: Yes  

    Keywords provided by University Hospital Inselspital, Berne:

    HIV
    Hepatitis B
    Renal dysfunction
    tenofovir alafenamide

    Additional relevant MeSH terms:
    Hepatitis
    Hepatitis B
    Renal Insufficiency
    Coinfection
    Tenofovir

    ClinicalTrials.gov processed this data on December 18, 2017
    This information is provided by ClinicalTrials.gov.