A Single-Arm Study Evaluating the Efficay and Safety of Tenofovir DF,Lamivudine and Efavirenz in Adults With HIV/HBV Coinfection

NCT01751555 Phase 4 COMPLETED

This is a Phase 4 single-arm, post-marketing clinical trial evaluating the efficacy and safety of tenofovir disoproxil fumarate, lamivudine and efavirenz in adults with human immunodeficiency virus-1 and hepatitis B virus coinfection.

Details

Lead sponsor	National Center for AIDS/STD Control and Prevention, China CDC
Phase	Phase 4
Status	COMPLETED
Enrolment	100
Start date	2011-02
Completion	2013-06

Conditions

• Hiv

Interventions

• Regimen:TDF+3TC+EFV

Primary outcomes

• Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48 — one year
  HIV and HBV viral load decreases in patients taking the regimen

Countries

China