In this pilot study, the investigators would examine the safety and efficacy of integrase inhibitor-Raltegravir in the control of HIV/HBV co-infection.
There are in total more than 72939 HIV infected people reported in Yunnan, the largest number for any province in China. About 800 HIV inpatients are admitted to our hospital every year, amongst them about 10% co-infected with HBV. HIV and HBV co-infection patients must receive two drugs active against both HIV and HBV, for example Tenofovir disoproxil fumarate (TDF)+ lamivudine (3TC) or TDF+FTC. TDF and 3TC are nucleotide analogues that can inhibit both HIV and HBV DNA polymerases (Dore, Cooper et al. 2004). Combination therapy could decrease drug resistance. In China, TDF is a second-line drug of the national free ART program; however FTC is not in the list of free drugs. There is likely higher risk of causing drug resistance in treating HBV or HIV infection with 3TC or TDF monotherapy than combination therapy. Raltegravir inhibits the catalytic activity of HIV-1 integrase, and does not significantly inhibit human phosphoryl transferases including DNA polymerases α, β, and γ, and may have less adverse effects. In chronic HBV infection, HBV-DNA does integrate into human DNA which results in difficulty eradicating HBV from the patient's body. In this pilot study, the investigators would examine the safety and efficacy of integrase inhibitor-Raltegravir in the control of HIV/HBV co-infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
raltegravir 400mg BID and tenofovir 300mg qd and lamivudine 300mg gd for 48 weeks
efavirenz 600mg QN +tenofovir 300mg qd +lamivudine 300mg qd for 48 weeks
Yunnan Provincial Hospital of Infectious Diseases/Yunnan AIDS Care Center
Kunming, Yunnan Provice, China
Frequency and severity of adverse events
The investigators will collect the adverse events at every follow-up, and record them in CRFs. All AEs during the study will be analyzed according to the type, frequency and severity.
Time frame: In 48 weeks (from baseline to study completion at 48 weeks)
Change of plasma HIV-1 RNA levels
Time frame: week 0,24 and 48
Change of Peripheral blood CD4 cell counts
Time frame: week 0,4,8,12,24,36 and 48
Change of plasma HBV-DNA levels
Time frame: week 0,12,24,36,and 48
Change of serum total bilirubin levels(TBI)
Time frame: week 0,2,4,8,12,24,36 and 48
Proportion of subjects with HBeAg seroconversion (HBeAg loss and presence of anti HBe)
Time frame: week 0,12,24,36,and week 48
Emergence of drug resistance mutations, if appropriate
Time frame: week 0, 24 and 48
Paired liver biopsy comparison according to inflammatory activity and fibrosis score
Time frame: week 0 and 48
Change of serum alanine aminotransferase levels (ALT)
Time frame: week 0,2,4,8,12,24,36 and 48
Change of serum aspartate aminotransferase levels (AST)
Time frame: week 0,2,4,8,12,24,36 and 48
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Change of blood urine nitrogen levels (BUN)
Time frame: week 0,2,4,8,12,24,36 and 48
Change of serum creatinine levels (SCr)
Time frame: week 0,2,4,8,12,24,36 and 48
Change of blood haemoglobin levels (HB)
Time frame: week 0,2,4,8,12,24,36 and 48
Change of white blood cell counts (WBC)
Time frame: week 0,2,4,8,12,24,36 and 48
Change of blood platelet counts (PLT)
Time frame: week 0,2,4,8,12,24,36 and 48
Change of urine protein levels
Time frame: week 0,2,4,8,12,24,36 and 48