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

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ClinicalTrials.gov Identifier: NCT00127959
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : April 24, 2007
Sponsor:
Collaborator:
Gilead Sciences
Information provided by:
International Antiviral Therapy Evaluation Center

Study Description
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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)


Condition or disease Intervention/treatment Phase
HIV Infections Hepatitis B Drug: tenofovir Drug: emtricitabine Drug: zidovudine Drug: efavirenz Phase 4

Detailed Description:

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIV/HBV co-Infection
Study Start Date : March 2004
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy

Secondary Outcome Measures :
  1. Proportion of patients with undetectable HBV DNA in serum
  2. Rate of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) seroconversion
  3. Rate of emergence of lamivudine (LAM)-resistant HBV genotypes
  4. Suppression of plasma HIV-RNA (< 50 copies/ml)
  5. Changes in CD4+ /CD8+ cell counts
  6. Presence of covalently closed circle DNA (cccDNA) on liver biopsy

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127959


Locations
Netherlands
Academic Medical Center
Amsterdam, NH, Netherlands, 1105AZ
Sponsors and Collaborators
International Antiviral Therapy Evaluation Center
Gilead Sciences
Investigators
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)
More Information
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ClinicalTrials.gov Identifier: NCT00127959     History of Changes
Other Study ID Numbers: IAT-0038-04
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: April 24, 2007
Last Verified: April 2007

Keywords provided by International Antiviral Therapy Evaluation Center:
HIV-1
HBV
treatment
tenofovir
 emtricitabine
Treatment Naive
HIV-1 infection
Hepatitis B virus infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
HIV Infections
Hepatitis B
Coinfection
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
 Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Parasitic Diseases
Tenofovir
Emtricitabine
Efavirenz
Zidovudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors