Efficacy and Safety of TDF+3TC+EFV 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single-Arm Study Evaluating the Efficay and Safety of Tenofovir DF,Lamivudine and Efavirenz in Adults With HIV/HBV Coinfection|
- Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48 [ Time Frame: one year ] [ Designated as safety issue: No ]HIV and HBV viral load decreases in patients taking the regimen
- Incidence of targeted adverse events over 48 weeks [ Time Frame: week 12,24,48 ] [ Designated as safety issue: Yes ]Clinical and laboratory safety(liver, renal, hematologic)of TDF+3TC+EFV for HIV/HBV co-infected patients
- CD4+ cell count increase at week 48 [ Time Frame: one year ] [ Designated as safety issue: No ]CD4+ cell count increases in patients receving the regimen
|Study Start Date:||February 2011|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: TDF/3TC/EFV Treatment HIV/HBV Co-infection
TDF+3TC+EFV treatment regimen in Adults with HIV/HBV Coinfection
TDF+3TC+EFV for HIV/HBV co-infection
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.
|National Center for AIDS/STD Control and Prevention, China CDC|
|Beijing, Beijing, China, 102206|
|Principal Investigator:||Fujie ZHANG, MD||National Center for AIDS/STD Control and Prevention, China CDC|