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

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ClinicalTrials.gov Identifier: NCT01751555
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : June 28, 2013
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
National Center for AIDS/STD Control and Prevention, China CDC

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hiv Drug: Regimen:TDF+3TC+EFV Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lamivudine
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. CD4+ cell count increase at week 48 [ Time Frame: one year ]
    CD4+ cell count increases in patients receving the regimen


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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):

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
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: December 2010

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