Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations
研究概览
简要总结
The main objective is to evaluate the hepatic safety of raltegravir when compared to efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment in patients with HIV and hepatitis C coinfection.
详细描述
The trial will recruit 80 treatment-naive HIV-infected patients with chronic hepatitis C coinfection from two HIV treatment centers in Vietnam. Patients will be randomized to receive either raltegravir or efavirenz, both in combination of tenofovir and emtricitabine, as first-line HIV therapy over a period of 72 weeks. The primary endpoint is the rate of alanine aminotransferase (ALT) elevation during the 72 week study period. Secondary endpoints include rates of virological suppression, CD4 count change, numbers of AIDS events and death, rates of fasting glucose and cholesterol measures, neurocognitive function and levels of immune activation. Patients will be followed monthly for the first 3 months and every 3 months thereafter. At the end of the trial period, patients will be transferred to the National HIV treatment program for continuation of HIV therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infected patients, age >18 years, meet Vietnam guideline to begin ART (CD4 count < 350 cells/mm3 and/or WHO stage III or IV disease)
- •Hepatitis C infection as documented by positive HCV antibodies and a detectable serum HCV RNA level
- •AST and ALT ≤ 2 x ULN (≤ 80 U/L)
- •Estimated creatinine clearance ≥ 60 mL/min
排除标准
- •Any prior ART
- •Positive Hepatitis B surface antigen
- •Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding)
- •Requirement for acute therapy for other AIDS-defining illness within 14 days prior to study entry
- •Currently on rifampicin therapy
- •In the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period
研究组 & 干预措施
Raltegravir based therapy
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
干预措施: Raltegravir (Drug)
Efavirenz based therapy
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
干预措施: Efavirenz (Drug)
结局指标
主要结局
Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations
时间窗: over week 72
To estimate the rates of grade 2\*and higher ALT elevations in the two regimens.
次要结局
未报告次要终点