Hiv Clinical Trial
Official title:
A Single-Arm Study Evaluating the Efficay and Safety of Tenofovir DF,Lamivudine and Efavirenz in Adults With HIV/HBV Coinfection
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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