NCT00967187已完成2 期
A Phase II Multicenter, Open-label, Randomized, Parallel Group, Study of Bevirimat in HIV-1 Positive Patients to Evaluate the Safety, Efficacy, and Pharmacokinetics of MPC-4326 Administered as Monotherapy for 14 Days and as Part of an Optimized Background Regimen for up to 72 Weeks.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Myrexis Inc.
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Change in HIV-1 viral load from baseline to day 15
研究概览
简要总结
To evaluate the antiretroviral activity and safety of 200 mg BID and 300 mg BID doses of MPC-4326 administered as monotherapy for 14 days to HIV-1 positive patients. Patients with an initial treatment response will have the option to continue MPC-4326 in combination with an Optimized Backround Regimen for a maximum of 72 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
- •Be at least 18 years of age at the time of screening.
- •Have HIV-1-infection.
- •Have a CD4+-lymphocyte count≥100 cells/mm3
- •Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of 2,000 - 500,000 copies/mL (inclusive).
- •Be free from any acute infection or serious medical illness within 14 days prior to study entry.
排除标准
- •Current opportunistic infection characteristic of AIDS (Category C according to the CDC Classification System for HIV-1 Infection, 1993 Revised Version, Appendix A) that is diagnosed within 30 days or is poorly controlled.
- •Patients with systolic blood pressure < 90 mmHg or > 140 mmHg or diastolic blood pressure < 60 mmHg or > 90 mmHg.
- •A history of seizures (excluding pediatric febrile seizures) or current administration of prophylactic anti-seizure medications.
- •A history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA).
- •Patients with the following laboratory parameters within 30 days prior to first dose of study drug: Hemoglobin < 10.0 g/dL for men and < 9.0 g/dL for women Neutrophil count < 1000/mm3 Platelet count < 50,000/mm3 AST or ALT > 2.5 times the upper limit of normal (patients with a positive HBV surface antigen or HCV antibody test at screening must have AST and ALT no more than 1.5 times the upper limit of normal)
研究组 & 干预措施
MPC-4326 200 mg BID X 14 Days
Experimental
干预措施: bevirimat dimeglumine (Drug)
MPC-4326 300 mg BID X 14 Days.
Experimental
干预措施: bevirimat dimeglumine (Drug)
结局指标
主要结局
Change in HIV-1 viral load from baseline to day 15
时间窗: 15 days
次要结局
- To evaluate safety and tolerability(72 weeks)
研究者
研究点 (4)
Loading locations...
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