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

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Antiviral Therapy Evaluation Center
• Collaborator: Gilead Sciences
• Treatments: Efavirenz; Emtricitabine; Tenofovir; Zidovudine

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)