NCT00127959

Brief Summary

This is a randomized multicentre trial of emtricitabine (FTC) versus tenofovir (TDF)/FTC in antiretroviral naive subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic substudy comparing a subgroup of patients on Clinical Trial A is being conducted. (Substudy A1)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Mar 2004

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

March 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

April 24, 2007

Status Verified

April 1, 2007

First QC Date

August 8, 2005

Last Update Submit

April 23, 2007

Conditions

HIV InfectionsHepatitis B

Keywords

HIV-1HBVtreatmenttenofoviremtricitabineTreatment NaiveHIV-1 infectionHepatitis B virus infection

Outcome Measures

Primary Outcomes (1)

  • HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy

Secondary Outcomes (6)

  • Proportion of patients with undetectable HBV DNA in serum

  • Rate of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) seroconversion

  • Rate of emergence of lamivudine (LAM)-resistant HBV genotypes

  • Suppression of plasma HIV-RNA (< 50 copies/ml)

  • Changes in CD4+ /CD8+ cell counts

  • +1 more secondary outcomes

Interventions

tenofovirDRUG
emtricitabineDRUG
zidovudineDRUG
efavirenzDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Documented HIV infection
  • Age 18 - 70 years
  • HBV DNA \> 10E6 copies/ml
  • ALT \< 10 x ULN (upper limit of normal)
  • Creatinine \<= 2.0mg/dl
  • Platelet count \>= 50,000/mm3
  • HIV-1 therapy naive
  • No prior exposure to anti-HBV agents

You may not qualify if:

  • Hepatitis C viral RNA (CV-RNA) positive or Anti-hepatitis A virus immunoglobulin M (HAV IgM) positive
  • Acute hepatitis (serum ALT \> 1000 U/L)
  • Prior LAM, TDF, or adefovir dipivoxil (ADV) therapy
  • Active opportunistic infection
  • Pregnancy or lactation
  • Other chronic liver disease
  • Concurrent malignancy requiring cytotoxic chemotherapy
  • Decompensated or Child's C cirrhosis
  • Alfa-fetoprotein (AFP) \> 3X ULN (unless negative computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\] within 3 months of entry date)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

HIV InfectionsHepatitis B

Interventions

TenofovirEmtricitabineZidovudineefavirenz

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesThymidineDideoxynucleosides

Study Officials

  • Joep M.A. Lange, MD PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    STUDY CHAIR

  • Kiat Ruxrungtham, MD PhD

    HIVNAT Bangkok

    PRINCIPAL INVESTIGATOR

  • Jan Prins, MD PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

March 1, 2004

Study Completion

August 1, 2006

Last Updated

April 24, 2007

Record last verified: 2007-04

Locations

NL(1)