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

Purpose

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.

Condition	Intervention	Phase
Hiv	Drug: Regimen:TDF+3TC+EFV	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Single-Arm Study Evaluating the Efficay and Safety of Tenofovir DF,Lamivudine and Efavirenz in Adults With HIV/HBV Coinfection

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine

U.S. FDA Resources

Further study details as provided by National Center for AIDS/STD Control and Prevention, China CDC:

Primary Outcome Measures:

Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48 [ Time Frame: one year ]
HIV and HBV viral load decreases in patients taking the regimen

Secondary Outcome Measures:

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

Other Outcome Measures:

CD4+ cell count increase at week 48 [ Time Frame: one year ]
CD4+ cell count increases in patients receving the regimen


Enrollment:	100
Study Start Date:	February 2011
Study Completion Date:	June 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751555

Locations


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

Sponsors and Collaborators

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

Gilead Sciences

Investigators


Principal Investigator:	Fujie ZHANG, MD	National Center for AIDS/STD Control and Prevention, China CDC

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier:	NCT01751555 History of Changes
Other Study ID Numbers:	co-us-104-0405
Study First Received:	December 14, 2012
Last Updated:	June 27, 2013

Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:


HBV co-infection ART TDF

Additional relevant MeSH terms:


Coinfection Infection Virus Diseases Parasitic Diseases

ClinicalTrials.gov processed this record on June 23, 2017