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

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 Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Drug: Regimen:TDF+3TC+EFV

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102206
      • National Center for AIDS/STD Control and Prevention, China CDC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD4+ cell count increase at week 48	CD4+ cell count increases in patients receving the regimen	one year

Collaborators and Investigators

• Sponsor: National Center for AIDS/STD Control and Prevention, China CDC
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Fujie ZHANG, MD, National Center for AIDS/STD Control and Prevention, China CDC

Publications and helpful links

General Publications

• G Matthews, A Avihingsanon, S Lewin, and others. Tenofovir-based Highly Active Antiretroviral Therapy (HAART) is associated with high rates of HBV DNA suppression and HBeAg seroconversion in Thai HIV-HBV coinfected patients. 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008). San Francisco. October 31-November 4, 2008. Abstract 907. O Lada, A Gervais, M Branger, and others. De Novo Combination Therapy of Tenofovir Disoproxil Fumarate (TDF) Plus Lamivudine (LAM) or TDF Plus Emtricitabine (FTC) Is Associated With Early Virologic Response in HIV/HBV Co-Infected Patients. 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2008). San Francisco. October 31-November 4, 2008. Abstract 922.
• Wu YS, Zhang WW, Ling XM, Yang L, Huang SB, Wang XC, Wu H, Cai WP, Wang M, Wang H, Liu YF, He HL, Wei FL, Wu ZY, Zhang FJ. Efficacy and Safety of Tenofovir and Lamivudine in Combination with Efavirenz in Patients Co-infected with Human Immunodeficiency Virus and Hepatitis B Virus in China. Chin Med J (Engl). 2016 Feb 5;129(3):304-8. doi: 10.4103/0366-6999.174509.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 14, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 18, 2012

Study Record Updates

• Last Update Posted (Estimate): June 28, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: HBV co-infection ART TDF
• Additional Relevant MeSH Terms: Infections; Coinfection
• Other Study ID Numbers: co-us-104-0405