Combination therapy with anti-HBV activity may both increase HBV suppression rates and reduce emergence of resistant strains. Several new therapeutic agents are currently in development, however combination therapy trials in the HBV-infected population have only recently commenced. No such trials have been undertaken in the HIV/HBV co-infected population.
The primary study objective is to compare HBV DNA suppression to levels below the limit of detection (\<400 copies/ml) by week 48 in each treatment group. Virological and clinical anti-HBV efficacy of tenofovir and emtricitabine in antiretroviral naive patients with HIV/HBV co-infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Emtricitabine 200 mg OD + Zidovudine 300 mg BID + EFV OD compared to TDF + FTC + EFV
HIV-NAT Thai Red Cross AIDS Research Center
Bangkok, Thailand
HBV DNA suppression to levels below the limit of detection (<400 copies/ml)
Time frame: week 48
HBV suppression as measured by comparison of AUC measurements at 12 and 24 weeks
Time frame: 12 and 24 weeks
Proportion of patients with undetectable HBV DNA in serum at 12 and 24 weeks
Time frame: 12 and 24 weeks
Rate of HBeAg and HBsAg seroconversion at 12, 24 and 48 weeks.
Time frame: 12, 24 and 48 weeks
Rate of emergence of LAM-resistant HBV genotypes at 48 weeks.
Time frame: 48 weeks
Rate of hepatic cytolysis (ALT level > 5x ULN).
Time frame: 48 weeks
Change from baseline in ALT levels and time to ALT normalization.
Time frame: 48 weeks
Suppression of plasma HIV-RNA (< 50 copies/ml) through 48 weeks.
Time frame: 48 weeks
Changes in CD4+ /CD8+ cell counts through 48 weeks
Time frame: 48 weeks
Toxicity
Time frame: 48 weeks
Assessment of effect of therapy on histological changes in the liver and effect on ccc-HBV-DNA
Time frame: 48 weeks
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