CompletedPhase 2

TAF for HIV-HBV With Renal Dysfunction

Switzerland24 participantsStarted 2017-05-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in renal function

Timeframe: 48 weeks

HBV suppression

Timeframe: 48 weeks

Trial details

NCT IDNCT03115736

SponsorInsel Gruppe AG, University Hospital Bern

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-05

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