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

This study has been completed.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier:
NCT01751555
First received: December 14, 2012
Last updated: June 27, 2013
Last verified: December 2010
  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: Endpoint Classification: Safety/Efficacy Study
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:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: China: Food and Drug Administration

Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:
HBV co-infection ART TDF

Additional relevant MeSH terms:
Coinfection
Infection
Parasitic Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014