NCT01751555

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 hiv

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 28, 2013

Status Verified

December 1, 2010

Enrollment Period

2.3 years

First QC Date

December 14, 2012

Last Update Submit

June 27, 2013

Conditions

Hiv

Keywords

HBV co-infection ART TDF

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with HIV RNA below LDL and HBV DNA below 2.3log10 copies/ml at week 48

    HIV and HBV viral load decreases in patients taking the regimen

    one year

Secondary Outcomes (1)

  • Incidence of targeted adverse events over 48 weeks

    week 12,24,48

Other Outcomes (1)

  • CD4+ cell count increase at week 48

    one year

Study Arms (1)

TDF/3TC/EFV Treatment HIV/HBV Co-infection

EXPERIMENTAL

TDF+3TC+EFV treatment regimen in Adults with HIV/HBV Coinfection

Drug: Regimen:TDF+3TC+EFV

Interventions

Regimen:TDF+3TC+EFVDRUG

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

TDF/3TC/EFV Treatment HIV/HBV Co-infection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 102206, China

Location

Related Publications (2)

  • 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.

    BACKGROUND

  • 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.

    PMID: 26831232DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Fujie ZHANG, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2012

First Posted

December 18, 2012

Study Start

February 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 28, 2013

Record last verified: 2010-12

Locations

CN(1)