NCT00002227已完成2 期
A Phase II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Lamivudine in Antiretroviral Therapy-Naive HIV-Infected Patients
Dupont Merck16 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2001年8月31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
- 入组人数
- 60
- 试验地点
- 16
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus lamivudine to patients who have never taken anti-HIV drugs.
详细描述
Patients will be given combination treatment with efavirenz, stavudine, and lamivudine.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Documented diagnosis of HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml.
- •Life expectancy of at least 12 months.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Current bilateral peripheral neuropathy greater than or equal to Grade
- •Proven or suspected acute hepatitis due to any cause.
- •Recurrent episodes of moderate to severe diarrhea, or vomiting lasting for more than 4 days within 3 months prior to dosing.
- •Hypersensitivity to any component of the formulation of efavirenz, stavudine, or lamivudine.
- •Any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values).
- •Any clinically significant disease (other than HIV infection) or clinically significant findings found during the screening of medical history or physical examination.
- •Any malignancy that requires systemic therapy.
- •Any active AIDS-defining opportunistic infection or disease.
- •Concurrent Medication:
- •Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine or any medications contraindicated for concomitant use with stavudine or lamivudine as described in the current information package insert.
- •Patients with the following prior conditions are excluded:
- •History of acute or chronic pancreatitis.
- •A life expectancy of less than 12 months.
- •Difficulty swallowing capsules/tablets.
- •Inability to communicate effectively with study personnel.
- •Prior Medication:
- •Any other experimental drug within 30 days of introducing study treatment.
- •Vaccination within 3 weeks of screening visit.
- •Any prior antiretroviral therapy.
- •Interferon started within 30 days of initiating study treatment.
- •Risk Behavior:
- •Current alcohol or illicit drug use which interferes with patient's ability to follow study regimen.
研究者
研究点 (16)
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