HIV and Hepatitis B CoinfectionPhase 2NCT03115736
TAF for HIV-HBV With Renal Dysfunction
A Phase 2 study testing Tenofovir Alafenamide in people with HIV and Hepatitis B Coinfection, run by Insel Gruppe AG, University Hospital Bern at 8 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV and Hepatitis B Coinfection
- What is being tested?
- Tenofovir Alafenamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 8 sitesSwitzerland
- Study dates
- 23 May 2017to 5 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Study drug considered by the treating physician not a valid option for the patient
- Pregnancy
- Decompensated liver cirrhosis
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Switzerland8 sites
Klinik für Infektiologie und Spitalhygiene, Universitätspital Basel
Basel, 4031
Inselspital
Bern, 3010
Department of Infectious Diseases, Hôpitaux Universitaires de Genève
Geneva, 1211
Cabinet médical Chave-Crottaz-Roggerto
Lausanne, Canton of Vaud, 1004
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Vaude, 1011
Ospedale Regionale di Lugano
Lugano, Canton Ticino, 6903
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
Klinik für Infektionskrankheiten & Spitalhygiene, Universitätsspital Zürich
Zurich, 8091
About this study
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
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.
Read the 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.
- Conditions
- HIV and Hepatitis B Coinfection
- Being tested
- Tenofovir Alafenamide
- Keywords
- HIV, Hepatitis B, Renal dysfunction, tenofovir alafenamide
- Medical subject headings
- Hepatitis B, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir AlafenamideDrug
Patients are switched to either Genvoya (TAF/FTC/EVG/COB) or another FTC/TAF-containing ART regimen
| Study group | Role | What they receive |
|---|---|---|
| Switch | Experimental | Patients are switched from a TDF-containing antiretroviral therapy regimen to a TAF-containing regimen Receives: Drug: Tenofovir Alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in renal function
Assessment of change in eGFR and tubular markers during the first year of TAF-containing ART
Measured: 48 weeks
HBV suppression
Evaluation of HBV virological suppression and HBsAg loss after 12 months of TAF
Measured: 48 weeks
Secondary outcomes (3)
Treatment interruptions
Description of the proportion of patients with treatment changes or interruptions
Measured: 48 weeks
Adverse events
Evaluation of the proportion of patients with adverse events during therapy, including grade 2 or above transaminases elevations
Measured: 48 weeks
Liver fibrosis change
Assessment of the proportion of patients with a change in liver fibrosis stage
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start23 May 2017
- Primary completion5 Dec 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV and Hepatitis B CoinfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Wandeler, MD MSc, Study chair, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115736
- Sponsor's protocol ID
- INSEL-HINF-2017-1
- Status last verified
- Mar 2020
- First submitted
- 10 Apr 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32925387
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03115736
- Acronym / sponsor ID
- INSEL-HINF-2017-1
- Conditions
- HIV and Hepatitis B Coinfection
- Keywords
- HIV, Hepatitis B, Renal dysfunction, tenofovir alafenamide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Switch | Experimental | Drug: Tenofovir AlafenamidePatients are switched from a TDF-containing antiretroviral therapy regimen to a TAF-containing regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Study drug considered by the treating physician not a valid option for the patient
- Pregnancy
- Decompensated liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir AlafenamidePatients are switched to either Genvoya (TAF/FTC/EVG/COB) or another FTC/TAF-containing ART regimen | Drug | Switch |
Primary outcome
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
3 secondary outcomes
Treatment interruptions
Time frame: 48 weeks
Adverse events
Time frame: 48 weeks
Liver fibrosis change
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 32925387Surial 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Wandeler, MD MSc study chair
Insel Gruppe AG, University Hospital Bern
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenofovir Alafenamide in people with HIV and Hepatitis B Coinfection, run by Insel Gruppe AG, University Hospital Bern at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in renal function (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03115736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.