HIV Infections Clinical Trial
Official title:
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIV/HBV co-Infection
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)
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)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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