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TAF for HIV-HBV With Renal Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115736
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

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 or disease Intervention/treatment Phase
HIV and Hepatitis B Coinfection Drug: Tenofovir Alafenamide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
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
Actual Study Start Date : May 23, 2017
Actual Primary Completion Date : December 5, 2019
Actual Study Completion Date : December 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in renal function [ Time Frame: 48 weeks ]
    Assessment of change in eGFR and tubular markers during the first year of TAF-containing ART

  2. HBV suppression [ Time Frame: 48 weeks ]
    Evaluation of HBV virological suppression and HBsAg loss after 12 months of TAF


Secondary Outcome Measures :
  1. Treatment interruptions [ Time Frame: 48 weeks ]
    Description of the proportion of patients with treatment changes or interruptions

  2. Adverse events [ Time Frame: 48 weeks ]
    Evaluation of the proportion of patients with adverse events during therapy, including grade 2 or above transaminases elevations

  3. Liver fibrosis change [ Time Frame: 48 weeks ]
    Assessment of the proportion of patients with a change in liver fibrosis stage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115736


Locations
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Switzerland
Kantonsspital St. Gallen
St. Gallen, Saint Gallen, Switzerland, 9007
Ospedale Regionale di Lugano
Lugano, Ticino, Switzerland, 6903
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Vaude, Switzerland, 1011
Cabinet médical Chave-Crottaz-Roggerto
Lausanne, Vaud, Switzerland, 1004
Klinik für Infektiologie und Spitalhygiene, Universitätspital Basel
Basel, Switzerland, 4031
Inselspital
Bern, Switzerland, 3010
Department of Infectious Diseases, Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1211
Klinik für Infektionskrankheiten & Spitalhygiene, Universitätsspital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Chair: Gilles Wandeler, MD MSc University Hospital Inselspital, Berne
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03115736    
Other Study ID Numbers: INSEL-HINF-2017-1
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Hospital Inselspital, Berne:
HIV
Hepatitis B
Renal dysfunction
tenofovir alafenamide
Additional relevant MeSH terms:
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Coinfection
Hepatitis B
Hepatitis
Renal Insufficiency
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Kidney Diseases
Urologic Diseases
Infection
Parasitic Diseases
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents