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

December 14, 2012
June 27, 2013
February 2011
June 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01751555 on ClinicalTrials.gov Archive Site
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
Same as current
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
Same as current
 
Efficacy and Safety of TDF+3TC+EFV in Adults With HIV/HBV Coinfection
A Single-Arm Study Evaluating the Efficay and Safety of Tenofovir DF,Lamivudine and Efavirenz in Adults With HIV/HBV Coinfection

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hiv
Drug: Regimen:TDF+3TC+EFV
TDF+3TC+EFV for HIV/HBV co-infection
Experimental: TDF/3TC/EFV Treatment HIV/HBV Co-infection
TDF+3TC+EFV treatment regimen in Adults with HIV/HBV Coinfection
Intervention: Drug: Regimen:TDF+3TC+EFV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01751555
co-us-104-0405
Yes
National Center for AIDS/STD Control and Prevention, China CDC
National Center for AIDS/STD Control and Prevention, China CDC
Gilead Sciences
Principal Investigator: Fujie ZHANG, MD National Center for AIDS/STD Control and Prevention, China CDC
National Center for AIDS/STD Control and Prevention, China CDC
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP