NCT00116415已完成不适用
Daily Antiretroviral Therapy (DART 1): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Didanosine Enteric Coated (Ddl-EC) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Patients
Bristol-Myers Squibb9 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2002年3月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 9
- 主要终点
- Estimate efficacy of ddI-EC/3TC/EFV given QD determined by proportion of patients with plasma HIV-1 RNA <400 copies/mL at 48 weeks
研究概览
简要总结
The purpose of this study is to evaluate whether a therapy with an all once daily regimen of efavirenz (EFV), didanosine (ddI)-EC and lamivudine (3TC) leads to improved outcomes, as measured by viral load, CD4 counts, adherence, safety, and tolerability.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older infected with HIV and weigh at least 40 kg.
- •Plasma HIV RNA viral load of 1000 copies/mL or greater and CD4 count of 100 cells/mL or greater
- •Be willing to use two forms of contraception throughout study
- •No previous exposure to antiretroviral (ARV) drugs
排除标准
- •Pregnancy or breastfeeding
- •Physical or psychiatric disability
- •Proven or suspected acute hepatitis within 30 days prior to study entry
- •Active AIDS-defining opportunistic infection or disease
- •History of acute or chronic pancreatitis
结局指标
主要结局
Estimate efficacy of ddI-EC/3TC/EFV given QD determined by proportion of patients with plasma HIV-1 RNA <400 copies/mL at 48 weeks
次要结局
- Evaluate patient adherence with QD regimen using pill counts and AMAF
- Determine pattern and emergence of HIV genotype resistance mutations in patients experiencing virologic failure
- Explore QoL changes using MOS-HIV health survey
- Evaluate safety and tolerability of QD regimen
- Evaluate proportion of patients with plasma HIV RNA <400 copies/mL at Weeks 24, 48, 72, and 96.
- Evaluate proportion of patients with plasma HIV RNA <50 copies/mL at Weeks 24, 48, 72, and 96
- Determine viral suppression of plasma HIV RNA from change in baseline at week 48
- Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks
- Evaluate time to undetectable plasma HIV RNA
- Evaluate proportion of patients demonstrating virologic breakthrough
- Evaluate proportion of patients demonstrating virologic failure
- Evaluate time to virologic breakthrough and virologic failure
- Measure magnitude and durability of changes in CD4 cell counts
研究者
研究点 (9)
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