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
|
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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 |
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 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 |
- HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy
- 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

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

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
Netherlands | |
Academic Medical Center | |
Amsterdam, NH, Netherlands, 1105AZ |
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) |
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 Zidovudine Efavirenz Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors |