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Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection

This study has been completed.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by:
International Antiviral Therapy Evaluation Center
ClinicalTrials.gov Identifier:
NCT00127959
First received: August 8, 2005
Last updated: April 23, 2007
Last verified: April 2007

August 8, 2005
April 23, 2007
March 2004
Not Provided
HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy
HBV DNA suppression as measured by comparison of AUC measurements after 48 weeks therapy
Complete list of historical versions of study NCT00127959 on ClinicalTrials.gov Archive Site
  • 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
  • Presence of covalently closed circle DNA (cccDNA) on liver biopsy
  • Proportion of patients with undetectable HBV DNA in serum
  • Rate of HBeAg and HBsAg seroconversion
  • Rate of emergence of LAM-resistant HBV genotypes
  • Suppression of plasma HIV-RNA (< 50 copies/ml)
  • Changes in CD4+ /CD8+ cell counts
  • Presence of cccDNA on liver biopsy
Not Provided
Not Provided
 
Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIV/HBV co-Infection

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)

This is a randomized multicentre trial of FTC vs 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)

Primary Objectives:

  • To compare the proportion of subjects with HBV DNA levels below the limit of detection (<400 copies/ml) by week 48 in each treatment group

Secondary Objectives:

  • To evaluate the emergence of HBV resistance at 48 weeks
  • To compare the proportion of patients with undetectable HBV DNA at weeks 12 and 24 in each treatment group
  • To compare the proportion of patients who achieve HBeAg and HBsAg seroconversion at weeks 12, 24 and 48 during the study
  • To compare changes in ALT from baseline and the rate of hepatic cytolysis (ALT>5x ULN)
  • To compare suppression of HIV-1 RNA and changes in CD4/CD8 counts over 48 weeks
  • To compare the effect of therapy on histological changes in the liver and the presence of ccc-DNA

Enrollment:

  • 24 patients in Clinical trial A (of whom 16 enter substudy A1).

Clinical Trial A:

  • Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viraemia and are willing to start antiretroviral therapy.

Inclusion Criteria:

  • Written informed consent
  • Documented HIV infection
  • Age 18 – 70 years
  • HBV DNA > 106 copies/ml

Randomization:

  • Arm 1: Zidovudine (AZT), emtricitabine (FTC), efavirenz (EFV)
  • Arm 2: Tenofovir (TDF), emtricitabine (FTC), efavirenz (EFV)
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hepatitis B
  • Drug: tenofovir
  • Drug: emtricitabine
  • Drug: zidovudine
  • Drug: efavirenz
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2006
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00127959
IAT-0038-04
No
Not Provided
International Antiviral Therapy Evaluation Center
Gilead Sciences
Study Chair: Joep M.A. Lange, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Kiat Ruxrungtham, MD PhD HIVNAT Bangkok
Principal Investigator: Jan Prins, MD PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
International Antiviral Therapy Evaluation Center
April 2007

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