NCT00135343已完成3 期
A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean percent change from baseline in fasting plasma triglycerides at Week 8
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Provide written informed consent
- •HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3
- •Antiretroviral (ARV) naive prior to enrollment
- •Normal plasma triglycerides ≤ 200 mg/dL
- •Women of child-bearing age must use effective barrier contraception
排除标准
- •Pregnancy or breast feeding
- •Evidence of resistance to antiretroviral drugs
- •History of elevated blood cholesterol or triglycerides
- •History of diabetes
- •Hypersensitivity to any component of the study drugs
- •Any cholesterol or triglyceride lowering medications in the past six months
- •Use of growth hormone, megestrol acetate, or anabolic steroids in the past six months
- •Imprisonment or involuntary incarceration for medical treatment
研究组 & 干预措施
A
Experimental
干预措施: Atazanvir/ritonavir + efavirenz (Drug)
B
Experimental
干预措施: Atazanvir/ritonavir + efavirenz (Drug)
结局指标
主要结局
Mean percent change from baseline in fasting plasma triglycerides at Week 8
次要结局
- Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48
- The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of a Nucleoside Sparing Regimen in HIV-1 Infected Patients With Detectable ViremiaHIV-1 InfectionNCT02542852Castagna Antonella10
已完成
4 期
NRTI-Sparing Pilot StudyHIVMitochondrial ToxicityNCT00143689University of British Columbia13
已完成
2 期
Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and TruvadaHIV InfectionsNCT00528060French National Agency for Research on AIDS and Viral Hepatitis35
已完成
3 期
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a InfectionChronic Hepatitis C InfectionNCT01833533AbbVie305
终止
4 期
Pilot Assessment of Lopinavir/Ritonavir and MaravirocAcquired Immunodeficiency SyndromeHIV InfectionsNCT00981318Rodwick, Barry M., M.D.3