An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Efficacy and Safety of Raltegravir-based Versus Efavirenz-based Combination Therapy in Treatment-naïve Patients With HIV-1 Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.
研究概览
简要总结
A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based combination therapy in treatment-naïve patients with HIV-1 infection.
详细描述
A single-center, prospective, randomized, open label, parallel study to compare the efficacy and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve patients with HIV-1 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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are infected with HIV-1
- •Patients have not yet received any treatment for HIV
- •Patients with HIV viral RNA exceeds 5000 copies per ml
- •Ages at least 20 years
排除标准
- •Patients with acute or decompensated chronic hepatitis
- •Patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range
- •Patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
- •Patients with any medical disorder that the use of study medications is contraindicated
- •Pregnant or breastfeeding women
- •Patients who are lack of expectation to maintain assigned study medication during study period
- •Patients who have received therapy with investigational drugs in the previous 3 months
研究组 & 干预措施
Raltegravir
Raltegravir 400mg oral twice daily
干预措施: Efavirenz (Drug)
Efavirenz
Efavirenz 600mg oral at bedtime
干预措施: Raltegravir (Drug)
结局指标
主要结局
The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.
时间窗: At week 48 of both arms
Virological response to achieve HIV RNA copies \<20 copies/mL at week 48 of both arms.
次要结局
- The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.(At week 48 of both arms)
- The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms.(At week 48 of both arms.)
- The Proportion of Treatment Failure at Week 48 for Both Arms.(At week 48 of both arms)