NCT00476463已完成2 期
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naive Patients With HIV/HBV Co-infection
The HIV Netherlands Australia Thailand Research Collaboration1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2005年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- HBV DNA suppression to levels below the limit of detection (<400 copies/ml)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)
- •Age 18 - 70 years
- •HBV DNA > 106 copies/ml
- •HBsAg positive for > 6 months
- •In case documented duration of HBsAg seropositive is less than 6 months (this situation is most likely to occur in patients newly presenting to the HIV-outpatient clinic) the patient is eligible if the patient is:
- •HBsAg positive and
- •HBc core IgM antibody negative and
- •the liver biopsy gives evidence for a chronic active hepatitis. Thus making it likely that this patient has acquired the HBV infection more than 6 months ago.
- •ALT < 10 x ULN
- •Creatinine <= 2.0mg/dl
- •Platelet count >= 50,000/mm3
- •HIV-1 therapy naive
- •No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed
排除标准
- •HCV-RNA positive or Anti-HAV IgM positive
- •Acute hepatitis (serum ALT > 1000 U/L)
- •Prior LAM, TDF, or ADV therapy
- •Active opportunistic infection
- •Other causes of chronic liver disease identified ( autoimmune hepatitis, haemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
- •Concurrent malignancy requiring cytotoxic chemotherapy
- •Decompensated or Child's C cirrhosis
- •Alfa-fetoprotein (AFP) > 3X ULN (unless negative CT scan or MRI within 3 months of entry date)
- •Pregnancy or lactation
- •Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study
研究组 & 干预措施
1
Active Comparator
AZT+FTC+EFV
干预措施: Emtricitabine (Drug)
2
Active Comparator
TDF+FTC+EFV
干预措施: Emtricitabine (Drug)
结局指标
主要结局
HBV DNA suppression to levels below the limit of detection (<400 copies/ml)
时间窗: week 48
次要结局
- Suppression of plasma HIV-RNA (< 50 copies/ml) through 48 weeks.(48 weeks)
- Changes in CD4+ /CD8+ cell counts through 48 weeks(48 weeks)
- Toxicity(48 weeks)
- Assessment of effect of therapy on histological changes in the liver and effect on ccc-HBV-DNA(48 weeks)
- HBV suppression as measured by comparison of AUC measurements at 12 and 24 weeks(12 and 24 weeks)
- Change from baseline in ALT levels and time to ALT normalization.(48 weeks)
- Proportion of patients with undetectable HBV DNA in serum at 12 and 24 weeks(12 and 24 weeks)
- Rate of HBeAg and HBsAg seroconversion at 12, 24 and 48 weeks.(12, 24 and 48 weeks)
- Rate of emergence of LAM-resistant HBV genotypes at 48 weeks.(48 weeks)
- Rate of hepatic cytolysis (ALT level > 5x ULN).(48 weeks)
研究者
研究点 (1)
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