NCT00127959已完成4 期
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIV/HBV co-Infection
International Antiviral Therapy Evaluation Center2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2004年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy
研究概览
简要总结
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)
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Documented HIV infection
- •Age 18 - 70 years
- •HBV DNA > 10E6 copies/ml
- •ALT < 10 x ULN (upper limit of normal)
- •Creatinine <= 2.0mg/dl
- •Platelet count >= 50,000/mm3
- •HIV-1 therapy naive
- •No prior exposure to anti-HBV agents
排除标准
- •Hepatitis C viral RNA (CV-RNA) positive or Anti-hepatitis A virus immunoglobulin M (HAV IgM) positive
- •Acute hepatitis (serum ALT > 1000 U/L)
- •Prior LAM, TDF, or adefovir dipivoxil (ADV) therapy
- •Active opportunistic infection
- •Pregnancy or lactation
- •Other chronic liver disease
- •Concurrent malignancy requiring cytotoxic chemotherapy
- •Decompensated or Child's C cirrhosis
- •Alfa-fetoprotein (AFP) > 3X ULN (unless negative computed tomography [CT] scan or magnetic resonance imaging [MRI] within 3 months of entry date)
结局指标
主要结局
HBV DNA suppression as measured by comparison of area under the curve (AUC) measurements after 48 weeks therapy
次要结局
- 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
研究者
研究点 (2)
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