Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT03425994
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03425994
Study Brief:
Protocol Section:
NCT03425994