A Phase 3b Open-label Study of the Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1/Hepatitis B Co-infected Adults

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222540

Enrollment

125

Registered

2014-06-25

Start date

2014-06-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1/HBV co-infection

Interventions

investigational material(s) Generic name etc : EVG/COBI/FTC/TAF INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational mater

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - HIV/HBV co-infected adults who are antiretroviral treatment-naive, whose plasma HIV-1 RNA level is 500 copies/mL or more and who also have chronic HBV infection, or HIV/HBV co-infected adults receiving an antiretroviral regimen who have maintained plasma HIV-1 RNA <50 copies/mL for 6 consecutive months and who also have chronic HBV infection

Exclusion criteria

Exclusion criteria: - A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening - Have an implanted defibrillator or pacemaker - Any history of, or current evidence of, clinical hepatic decompensation

Design outcomes

Primary

Measure	Time frame
- The percentage of subjects with plasma HBV DNA levels <29 IU/mL at Week 24. - The percentage of subjects with plasma HIV-1 RNA level <50 copies/mL at Week 24. - The percentage of subjects with normalized ALT at Weeks 24 and 48. etc.	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026