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

I

International Antiviral Therapy Evaluation Center

Status and phase

Completed
Phase 4

Conditions

Hepatitis B
HIV Infections

Treatments

Drug: emtricitabine
Drug: efavirenz
Drug: zidovudine
Drug: tenofovir

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00127959
IAT-0038-04

Details and patient eligibility

About

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)

Full 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)

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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