NCT03115736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2017

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 23, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

April 10, 2017

Last Update Submit

March 3, 2020

Conditions

HIV and Hepatitis B Coinfection

Keywords

HIVHepatitis BRenal dysfunctiontenofovir alafenamide

Outcome Measures

Primary Outcomes (2)

  • Change in renal function

    Assessment of change in eGFR and tubular markers during the first year of TAF-containing ART

    48 weeks

  • HBV suppression

    Evaluation of HBV virological suppression and HBsAg loss after 12 months of TAF

    48 weeks

Secondary Outcomes (3)

  • Treatment interruptions

    48 weeks

  • Adverse events

    48 weeks

  • Liver fibrosis change

    48 weeks

Study Arms (1)

Switch

EXPERIMENTAL

Patients are switched from a TDF-containing antiretroviral therapy regimen to a TAF-containing regimen

Drug: Tenofovir Alafenamide

Interventions

Tenofovir AlafenamideDRUG

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

Switch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Cabinet médical Chave-Crottaz-Roggerto

Lausanne, Canton of Vaud, 1004, Switzerland

Location

Ospedale Regionale di Lugano

Lugano, Canton Ticino, 6903, Switzerland

Location

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Vaude, 1011, Switzerland

Location

Klinik für Infektiologie und Spitalhygiene, Universitätspital Basel

Basel, 4031, Switzerland

Location

Inselspital

Bern, 3010, Switzerland

Location

Department of Infectious Diseases, Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Klinik für Infektionskrankheiten & Spitalhygiene, Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Surial B, Beguelin C, Chave JP, Stockle M, Boillat-Blanco N, Doco-Lecompte T, Bernasconi E, Fehr J, Gunthard HF, Schmid P, Walti LN, Furrer H, Rauch A, Wandeler G; and the Swiss HIV Cohort Study. Brief Report: Switching From TDF to TAF in HIV/HBV-Coinfected Individuals With Renal Dysfunction-A Prospective Cohort Study. J Acquir Immune Defic Syndr. 2020 Oct 1;85(2):227-232. doi: 10.1097/QAI.0000000000002429.

    PMID: 32925387DERIVED

MeSH Terms

Conditions

Hepatitis BRenal Insufficiency

Interventions

tenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Gilles Wandeler, MD MSc

    Insel Gruppe AG, University Hospital Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 14, 2017

Study Start

May 23, 2017

Primary Completion

December 5, 2019

Study Completion

December 5, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

CH(8)