NCT00116116已完成4 期
Daily Antiretroviral Therapy (DART-II): An Open-Label, Single-Arm, Prospective, Multicenter Clinical Trial To Evaluate the Efficacy and Safety fo Stavudine Extended Release (d4T XR) in Combination With Lamivudine (3TC) and Efavirenz (EFV) Once Daily in Anti-Retroviral Therapy (ART) Naive HIV-Infected Subjects
Bristol-Myers Squibb10 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2002年3月最近更新:
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试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Estimate efficacy of d4T-XR/3TC/EFV given QD determined by
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 stavudine extended release (d4T XR), lamivudine (3TC), and efavirenz (EFV) 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 d4T-XR/3TC/EFV given QD determined by
proportion of patients with plasma HIV RNA < 400 copies/mL after 48 weeks
次要结局
- Evaluate proportion of patients with plasma HIV RNA < 400 copies/mL at Weeks 24, 48, 72, and 96
- Evaluate the proportion of patients with plasma HIV RNA < 50 copies/mL at Weeks 24, 48, 72, and 96
- Determine viral suppression of plasma HIV RNA change in baseline at week 48
- Determine proportion of patients whose HIV viral load doesn't drop to undetectable level within 24 weeks of therapy initiation
- 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
- Evaluate patient adherence with QD regimen using pill counts and AMAF
- Determine pattern and emergence of HIV genotype resistance mutations in subjects experiencing virologic failure
- Explore QoL changes using MOS-HIV health survey
- Evaluate safety and tolerability of QD regimen
研究者
研究点 (10)
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