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)
Primary Outcome Measures:
- HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy
Secondary Outcome Measures:
- 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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| Estimated Enrollment: |
24 |
| Study Start Date: |
March 2004 |
| Study Completion Date: |
August 2006 |
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)
