Status:
COMPLETED
Virological and Clinical Anti-Hepatitis B Virus (HBV) Efficacy of Tenofovir and Emtricitabine in Patients With HIV/HBV co-Infection
Lead Sponsor:
International Antiviral Therapy Evaluation Center
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV Infections
Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 v...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00127959
Start Date
March 1 2004
End Date
August 1 2006
Last Update
April 24 2007
Active Locations (1)
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1
Academic Medical Center
Amsterdam, North Holland, Netherlands, 1105AZ