Status:
UNKNOWN
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide as Maintenance Treatment for HIV/HBV-coinfection
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Taiwan University Hospital Hsin-Chu Branch
National Taiwan University Hospital, Yun-Lin Branch
Conditions:
Chronic Hepatitis B in HIV Patient
Kidney Injury
Eligibility:
All Genders
20+ years
Brief Summary
Tenofovir alafenamide (TAF), active against both HIV and HBV, demonstrates similar antiviral efficacy but improved renal and bone safety compared to tenofovir disoproxil fumarate (TDF) in HIV-1-infect...
Eligibility Criteria
Inclusion
- Aged ≥ 20 years
- Diagnosed with HIV and HBV-coinfection. HBV infection is defined as positive HBsAg for 6 months or longer before enrollment of the study
- Serum HBV DNA load \<9 log10 IU/mL
- On Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) or TDF plus lamivudine (3TC) as backbone plus a 3rd agent for HIV infection for 6 months or longer
- Plasma HIV RNA load \<50 copies/mL twice over the past 12 months
- No known resistance mutations to Integrase strand transfer inhibitors (InSTIs), and no previous history of HIV treatment failure under InSTIs-containing combination antiretroviral therapy (cART). HIV treatment failure is defined as a plasma HIV RNA load \>400 copies/mL after 6 months of InSTIs-containing cART.
- No known resistance mutations to TDF, 3TC, or FTC, and no previous history of HIV treatment failure while on TDF, 3TC, or FTC-containing cART. HIV treatment failure is defined as a plasma HIV RNA load \>400 copies/mL after 6 months of TDF, 3TC, or FTC-containing cART.
- Baseline eGFR (estimated glomerular filtration rate) ≥30 mL/min per 1.73m2 (calculated by CKD-EPI equation)
- AST and ALT ≤2-fold the upper limit of normal
- Able to sign the written informed consent
Exclusion
- Active opportunistic illness
- On treatment of tuberculosis
- Pregnancy or lactation
- Hepatic decompensation (Child-Pugh C)
- Allergic to TDF, TAF, 3TC, FTC, or InSTIs
- Intolerance of InSTIs
- Hepatitis C virus (HCV)-coinfection and plan to start treatment with direct-acting antiviral agents or interferon/ribavirin within 48 weeks
- Concurrent use of rifamycins, phenytoin, and other drugs that are contraindicated with EVG/cob/FTC/TAF
Key Trial Info
Start Date :
February 6 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 11 2019
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT03425994
Start Date
February 6 2018
End Date
October 11 2019
Last Update
August 28 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan, 100