An Open-label, 36-week Extension Study on Amdoxovir at 500 mg Bid or 300 mg Bid in Combination With Zidovudine and Lopinavir/Ritonavir in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analog Mutations.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- HIV-1 viral load
研究概览
简要总结
This study is an open-label extension of RFSP-AMDX-2010 study for those subjects who received treatment with amdoxovir (300 mg or 500 mg twice daily) for 12 weeks and benefited from it. This study will examine the safety and efficacy of the investigational HIV drug, amdoxovir (300 mg and 500 mg bid doses; N = up to 30) in combination with zidovudine and lopinavir/ritonavir for 36 weeks.
Subjects will continue to receive either amdoxovir 300 mg twice daily or amdoxovir 500 mg twice daily, each in combination with zidovudine 300 mg twice daily and lopinavir/ritonavir (400 mg/100 mg twice daily) for additional 36 weeks.
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
- •Must have completed Study RFSP-AMDX-2010 and received treatment with amdoxovir (500 mg bid or 300 mg bid) for 12 weeks before entry into study RFSP-AMDX-
- •Must have maintained ≥ 1.0 log10 copies/mL from baseline at Week 12 in Study RFSP-AMDX-
- •Must not have had any serious adverse experience since enrollment in Study RFSP-AMDX-2010, whether or not considered to be study drug-related.
排除标准
- •Subjects who require ongoing therapy of nephrotoxic drugs or competitors of renal excretion.
- •Subjects who require therapy with hematologic, bone marrow suppressive or cytotoxic agents.
- •Subjects who require medications that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with life-threatening adverse events.
- •Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulations.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
amdoxovir 300 mg bid
in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.
干预措施: amdoxovir 300 mg bid (Drug)
amdoxovir 500 mg bid
in combination with zidovudine 300 mg bid and lopinavir/ritonavir (400 mg/100 mg bid) for 36 weeks.
干预措施: amdoxovir 500 mg bid (Drug)
结局指标
主要结局
HIV-1 viral load
时间窗: up to 48 Weeks
次要结局
- Incidence of adverse events(up to 48 Weeks)
- Changes in Immunologic Function (CD4 cell counts)(from baseline to Weeks 18, 24, 30, 36, 42, 48)