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

NCT ID: NCT01751555

Last Updated: 2013-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-06-30

Brief Summary

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

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.

Conditions

Hiv

Keywords

HBV co-infection ART TDF

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TDF/3TC/EFV Treatment HIV/HBV Co-infection

TDF+3TC+EFV treatment regimen in Adults with HIV/HBV Coinfection

Group Type: EXPERIMENTAL

Regimen:TDF+3TC+EFV

Intervention Type: DRUG

TDF+3TC+EFV for HIV/HBV co-infection

Interventions

Regimen:TDF+3TC+EFV

TDF+3TC+EFV for HIV/HBV co-infection

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fujie ZHANG, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 26831232 (View on PubMed)

Other Identifiers

co-us-104-0405

Identifier Type: -

Identifier Source: org_study_id