NCT00040157终止2 期
A Phase 2 Trial of 4 Weeks of ACH-126,443 in Comparison With Continued Lamivudine in Stable Triple Antiretroviral Combination Therapy in HIV-Infected Subjects With Modestly Detectable Viral Load
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 21
研究概览
简要总结
To determine safety and efficacy of ACH-126,443 on the treatment of adults with HIV infection who have modestly detectable viral load while on stable triple combination antiretroviral therapy including 3TC.
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
- Double
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
- •Adults ≥18 years of age
- •Receiving a stable triple combination antiretroviral regimen including 3TC, one other NRTI and either an NNRTI or a protease inhibitor for at least 4 months (16 weeks)
- •Demonstration of initial viral suppression and subsequent rebound to be defined as an initial virological drop of at least 0.5 Logs on a 3TC-containing regimen
- •Plasma HIV RNA level > 1000 and < 30,000 copies/mL on two occasions
- •Genotypically documented M184V variant of HIV RT
- •Clinically stable HIV status with no AIDS-defining events
- •CD4 > 200 cells/mm3
- •Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)
- •All women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L of b-HCG) within 72 hours prior to the start of study medication
- •No active opportunistic infection requiring treatment
- •Subject must be able to provide written informed consent
- •Baseline laboratory values measured within 28 days of initiating study drug as follows:
- •HGB≥9.0g/dl or HCT≥27% (in the absence of blood transfusions or erythropoietin treatment in the preceding two weeks
- •Absolute neutrophil count≥1000 cells/mm(^3) (in the absence of on-going G-CSF therapy
- •Platelet count ≥75,000/mm(^3)
- •AST <7.0 times the upper limit of normal
- •ALT ,7.0 times the upper limit of normal
- •Serum creatinine <1.1 times the upper limit of normal
- •Exclusion Criteria
- •Evidence of active HBV infection as demonstrated by HBsAg positivity
- •Hepatitis C co-infection
- •Concurrent systemic antiviral treatment
- •Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
- •Alcohol abuse
- •Pregnancy or breast-feeding
- •Inability to tolerate oral medication
- •AST > 7.0 times the upper limit of normal
- •ALT > 7.0 times the upper limit of normal
- •Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
- •Use of any other drug or substance with anti-HBV activity
排除标准
- 未提供
研究者
研究点 (21)
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