TAF for HIV-HBV With Renal Dysfunction | NCT03115736

Studies
TAF for HIV-HBV With Renal Dysfunction

NCT03115736

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Mar 4, 2020Actual

Enrollment

24Actual

Phase

Phase 2

Conditions

HIV and Hepatitis B Coinfection

Interventions

Tenofovir Alafenamide

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 23, 2017Actual

Primary Completion Date

Dec 5, 2019Actual

Completion Date

Dec 5, 2019Actual

First Submitted Date

Apr 10, 2017

First Submission Date that Met QC Criteria

Apr 10, 2017

First Posted Date

Apr 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2020

Last Update Posted Date

Mar 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Switch	Experimental	Patients are switched from a TDF-containing antiretroviral therapy regimen to a TAF-containing regimen	Drug: Tenofovir Alafenamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tenofovir Alafenamide	Drug	Patients are switched to either Genvoya (TAF/FTC/EVG/COB) or another FTC/TAF-containing ART regimen	Switch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Treatment interruptions	Description of the proportion of patients with treatment changes or interruptions	48 weeks
Adverse events	Evaluation of the proportion of patients with adverse events during therapy, including grade 2 or above transaminases elevations

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gilles Wandeler, MD MSc	Insel Gruppe AG, University Hospital Bern	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital St. Gallen		Sankt Gallen	Canton of St. Gallen	9007	Switzerland
Cabinet médical Chave-Crottaz-Roggerto

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32925387	Derived	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.

ID	Term
D006509	Hepatitis B
D051437	Renal Insufficiency

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections