Skip to main content
OpenTrials
Completed

NCT Number: NCT01751555

Efficacy and Safety of TDF+3TC+EFV 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Beijing, Beijing Municipality, 102206, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regimen:TDF+3TC+EFV

Drug

TDF+3TC+EFV for HIV/HBV co-infection

Primary outcomes

  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 outcomes

  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 outcomes

  1. CD4+ cell count increase at week 48

    Time frame: one year

    CD4+ cell count increases in patients receving the regimen

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 18, 2012
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.