Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Proportion of patients with viral load < 400 copies/ml at week S24
研究概览
简要总结
Lipodystrophie, peripheral neuropathy and mitochondrial toxicity has been associated to stavudine at standard doses The aim of this study is to evaluate the efficacy of reduced doses of stavudine (30 mg b.i.d.) in HIV patients with controlled viral load and body weight > 60 kg, receiving an antiretroviral therapy containing stavudine 40 mg b.i.d.
详细描述
Stavudine is a nucleoside inhibitor larged used in HIV treatments and has been associated to mithocondrial toxicity. As it is still largely used in developping countries,the evaluation of reducing dose is of importance.
A single-arm open pilot 48 weeks study to evaluate the capacity of a switch from d4T 40 mg to 30 mg bid in patients with body weight > 60kg to maintain full viral load suppression. Clinical and biological evaluations were carried out at baseline, W24 and W48. Primary end-point is viral load suppression (<400 coies/ml) at W24.
Secondary end-points are : Evolution of CD4 count at W24 and W48, neurological examination at Baseline, W24 and W48, metabolic parameters and stavudine PK at W24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV patients
- •Patients with an antiretroviral treatment containing stavudine at standard doses (40mg BID) for at least 3 months
- •Patients with viral load < 400 copies/ml for at least 3 months
排除标准
- •Patients receiving an antiretroviral therapy containing stavudine at 30mg BID
- •Current Opportunistic Infection
- •Current chemotherapy or under cytokines treatment (PEG, INF, IL2)
- •Pregnant or feeding Women
结局指标
主要结局
Proportion of patients with viral load < 400 copies/ml at week S24
次要结局
- Clinical and biological safety of the reduced doses of stavudine at week 24. Percentage of patients with viral load < 400 copies/ml at week 48, evolution of Cd4 count from baseline to W24 and 48. Evolution of metabolic parameters from baseline to W24 and