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

National Center for AIDS/STD Control and Prevention, China CDC

Status and phase

Completed

Phase 4

Conditions

Hiv

Treatments

Drug: Regimen:TDF+3TC+EFV

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01751555

co-us-104-0405

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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