TAF for HIV-HBV With Renal Dysfunction

• Status: Completed
• Trial end date: 2019-12-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Tenofovir

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