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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751555
• Other study ID #: co-us-104-0405
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2012
• Last updated: June 27, 2013
• Start date: February 2011
• Est. completion date: June 2013

Study information

• Verified date: December 2010
• Source: National Center for AIDS/STD Control and Prevention, China CDC
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coinfection
• Hiv

Intervention

Drug:
• Regimen:TDF+3TC+EFV
TDF+3TC+EFV for HIV/HBV co-infection

Locations

Country	Name	City	State
China	National Center for AIDS/STD Control and Prevention, China CDC	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
National Center for AIDS/STD Control and Prevention, China CDC	Gilead Sciences

Country where clinical trial is conducted

China, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CD4+ cell count increase at week 48	CD4+ cell count increases in patients receving the regimen	one year	No
Primary	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	No
Secondary	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	Yes