NCT00476463

Brief Summary

Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce emergence of resistant strains. Several new therapeutic agents are currently in development, however combination therapy trials in the HBV-infected population have only recently commenced. No such trials have been undertaken in the HIV/HBV co-infected population.

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_2

Timeline
Completed

Started Apr 2005

Typical duration for phase_2

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

April 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

3.7 years

First QC Date

May 20, 2007

Last Update Submit

February 18, 2016

Conditions

Hepatitis B VirusHIV Infections

Keywords

TDF+FTCFTCHIV/HBVTDF compared to TDF+FTC in HIV/HBVTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • HBV DNA suppression to levels below the limit of detection (<400 copies/ml)

    week 48

Secondary Outcomes (10)

  • HBV suppression as measured by comparison of AUC measurements at 12 and 24 weeks

    12 and 24 weeks

  • Proportion of patients with undetectable HBV DNA in serum at 12 and 24 weeks

    12 and 24 weeks

  • Rate of HBeAg and HBsAg seroconversion at 12, 24 and 48 weeks.

    12, 24 and 48 weeks

  • Rate of emergence of LAM-resistant HBV genotypes at 48 weeks.

    48 weeks

  • Rate of hepatic cytolysis (ALT level > 5x ULN).

    48 weeks

  • +5 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

AZT+FTC+EFV

Drug: Emtricitabine

2

ACTIVE COMPARATOR

TDF+FTC+EFV

Drug: Emtricitabine

Interventions

EmtricitabineDRUG

Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV

12

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)
  • Age 18 - 70 years
  • HBV DNA \> 106 copies/ml
  • HBsAg positive for \> 6 months
  • In case documented duration of HBsAg seropositive is less than 6 months (this situation is most likely to occur in patients newly presenting to the HIV-outpatient clinic) the patient is eligible if the patient is:
  • HBsAg positive and
  • HBc core IgM antibody negative and
  • the liver biopsy gives evidence for a chronic active hepatitis. Thus making it likely that this patient has acquired the HBV infection more than 6 months ago.
  • ALT \< 10 x ULN
  • Creatinine \<= 2.0mg/dl
  • Platelet count \>= 50,000/mm3
  • HIV-1 therapy naive
  • No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed

You may not qualify if:

  • HCV-RNA positive or Anti-HAV IgM positive
  • Acute hepatitis (serum ALT \> 1000 U/L)
  • Prior LAM, TDF, or ADV therapy
  • Active opportunistic infection
  • Other causes of chronic liver disease identified ( autoimmune hepatitis, haemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
  • Concurrent malignancy requiring cytotoxic chemotherapy
  • Decompensated or Child's C cirrhosis
  • Alfa-fetoprotein (AFP) \> 3X ULN (unless negative CT scan or MRI within 3 months of entry date)
  • Pregnancy or lactation
  • Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIV-NAT Thai Red Cross AIDS Research Center

Bangkok, 10330, Thailand

Location

Related Links

MeSH Terms

Conditions

Hepatitis BHIV Infections

Interventions

Emtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Kiat Ruxrungtham, MD

    HIV-NAT Thai Red Cross AIDS Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2007

First Posted

May 22, 2007

Study Start

April 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

TH(1)