NCT01751555

Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: National Center for AIDS/STD Control and Prevention, China CDC · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

HIV/HBV co-infections are frequently observed due to shared routes of transmission. TDF and 3TC are nucleotide analogues that can inhibit both HIV and HBV DNA polymerases. There is higher risk to cause drug resistance in treating HBV or HIV infection with 3TC or TDF monotherapy than combination trerapy. Combination tharapy could decreases drug resistance. China's HIV epidemic remains one of low prevalence overall, but with pockets of high infection among specific sub-populations and in some localities. China has a very high endemicity for hepatitis B too. A substantial proportion of HIV-infected individuals are co-infected with HBV. TDF + 3TC + EFV will be a common regimen for HIV/HBV co-infected Chinese individuals. The purpose of this study of this study is to determine whether TDF will be safe for patients with HIV and HBV co-infection and the combination of TDF+3TC+EFV will suppress HIV and HBV viral load below LDL at week 48 of treatment in patients with HIV and HBV co-infeciton.This study will enroll 100 adult subjects and follow these patients for 48 weekes.There will be one enrollment visit(baseline) and visits at 2,4,8,12,24,36,48 weeks after initiation of the study regimen.

Conditions

• Hiv

Interventions

Type	Name	Description
DRUG	Regimen:TDF+3TC+EFV	TDF+3TC+EFV for HIV/HBV co-infection

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-12-18
• Last updated: 2013-06-28

Locations

1 site across 1 country: China