NCT00002442已完成2 期
A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 Mg BID Versus Epivir 300 Mg Once-Daily When Administered for 24 Weeks in Combination With FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects With HIV-1 Infection
Glaxo Wellcome24 个研究点 分布在 1 个国家开始时间: 1999年6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
- 24
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.
详细描述
Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.
研究设计
- 研究类型
- Interventional
- 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 may be eligible for this study if they:
- •Are HIV-positive.
- •Are at least 18 years old.
- •Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry.
- •Have a CD4 cell count of at least 50 cells/mm
- •Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.)
- •Agree to abstain from sex or use effective methods of birth control during the study.
排除标准
- •Patients will not be eligible for this study if they:
- •Have a history of an AIDS-defining illness or certain other medical conditions.
- •Are allergic to any of the study drugs.
- •Are unable to take medication by mouth for any reason.
- •Have received certain medications.
- •Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study.
- •Are pregnant or breast-feeding.
研究者
研究点 (24)
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