NCT00004852已完成2 期
A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs. Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naive Adults With HIV-1 Infection
Glaxo Wellcome111 个研究点 分布在 4 个国家开始时间: 1999年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 111
研究概览
简要总结
The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.
详细描述
Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.
研究设计
- 研究类型
- Interventional
- 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
- •Patients may be eligible for this study if they:
- •Are 18 years of age or older.
- •Are HIV-positive.
- •Have a viral load (level of HIV in the blood) of at least 400 copies/ml within 21 days of study entry.
- •Have a CD4 count greater than 100 cells/mm3 within 21 days of study entry.
- •Agree to practice abstinence or use effective barrier methods of birth control (or, if patient is a woman, unable to have children).
排除标准
- •Patients will not be eligible for this study if they:
- •Have taken any antiretroviral (anti-HIV) agent.
- •Are pregnant or breast-feeding.
- •Are unable to absorb food or have trouble taking medicines by mouth.
- •Abuse alcohol or drugs to an extent that may make study participation difficult.
- •Are not likely to be able to complete the 48 weeks of study treatment.
- •Have a history of pancreatitis (inflamed pancreas) or hepatitis within the last 6 months or any evidence of liver disease.
- •Have received an investigational vaccine within the past 3 months or have received gene therapy.
- •Have a severe medical condition such as diabetes or heart trouble.
- •Have been diagnosed with AIDS.
- •Have had radiation therapy or chemotherapy within 30 days of study entry, except for treatment of Kaposi's sarcoma.
- •Are taking medications that affect the immune system within 30 days of study entry.
- •Are taking medications that may interact with the study drugs.
研究者
研究点 (111)
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