Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- • SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy
研究概览
简要总结
The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.
详细描述
The objective of this study is to evaluate the safety, efficacy and pharmacokinetics of sofosbuvir 400mg once daily plus ribavirin 1000-1200 mg daily in HIV-infected patients on fixed dose co-formulation emtricitabine/tenofovir/cobicistat/elvitegravir (Stribild).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Chronic HCV genotype 1 infection
- •Receiving emtricitabine/tenofovir/cobicistat/elvitegravir for at least 8 weeks.
- •CD4 count >200 cells/mm3 at screening and no CD4 count <200 in previous 12 weeks
- •HIV RNA PCR <50 copies/ml at screening and no HIV RNA PCR > 200 copies/ml in previous 12 weeks
排除标准
- •History of integrase inhibitor resistance
- •History of integrase inhibitor failure
- •Absolute neutrophil counts under 1500/mm3 ( Black/ African Americans <1200/mm3
- •Patients with cirrhosis
- •Platelet count under 90,000 per cubic millimeter
- •Hemoglobin levels <11 gm/dl in women or <12 gm/dl in men
- •Previous treatment with a DAA
- •Hepatocellular carcinoma
- •AFP>100 ng/mL
- •hepatitis B virus (HBsAg positive)
- •Evidence of decompensated liver disease including, but not limited to, a history of presence of clinical ascites, bleeding varices, or hepatic encephalopathy
研究组 & 干预措施
Sofossbuvir, Riabvirin, Stribild
Open-Label SIngle Arm of Sofosbuvir, Ribavirin and Stribild
干预措施: Sofosbuvir, Ribavirin, and Stribild (Drug)
结局指标
主要结局
• SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy
时间窗: 12 weeks post treatment
patients who have achieved non-detectable HCV levels 12 weeks post treatment
次要结局
未报告次要终点
研究者
Jihad Slim, MD
Chief and Prgram Director, Infectious Diseases
Saint Michael's Medical Center