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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hiv

Intervention / Treatment
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* Drug: Regimen:TDF+3TC+EFV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Serologically-confirmed HIV and HBV infection Willingness to participate in a clinical trial No previous or current use of antiretroviral regimen Clinical conditions stable Blood creatinine less than 3 times the upper limit of normal values. HBV DNA>1000copies/ml, Tbil<34umol/L,ALT<400U/L With clinical indications for HAART Exclusion Criteria: Patient refuses to sign the consent to participate Unwillingness to adhere to visit schedule or maintain adherence with medications Illnesses so serve as to likely require hospitalization With other conditions that not suitable to be enrolled will be subject to medical review

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TDF/3TC/EFV Treatment HIV/HBV Co-infection<br>TDF+3TC+EFV treatment regimen in Adults with HIV/HBV Coinfection | Drug: Regimen:TDF+3TC+EFV<br>* TDF+3TC+EFV for HIV/HBV co-infection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48 | HIV and HBV viral load decreases in patients taking the regimen | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of targeted adverse events over 48 weeks | Clinical and laboratory safety(liver, renal, hematologic)of TDF+3TC+EFV for HIV/HBV co-infected patients | week 12,24,48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV co-infection ART TDF