NCT00002207已完成不适用
A Randomized, Double-Blind Study of the Antiviral Activity of Once-Daily and Twice-Daily Dosing of Didanosine in Combination With Twice-Daily Dosing of Stavudine in HIV-Infected Subjects
Bristol-Myers Squibb13 个研究点 分布在 1 个国家开始时间: 2004年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 13
研究概览
简要总结
The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This study also examines the safety of giving ddI with d4T in the short-term.
详细描述
Patients are randomized to receive ddI given either qd or bid in combination with d4T given bid (no doses specified).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 must have:
- •Documented HIV infection.
- •CD4 cell count of at least 100 cells/mm
- •Plasma HIV RNA count of 10,000 copies/ml or more within 14 days prior to study entry.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions and symptoms are excluded:
- •Presence of a newly diagnosed AIDS-defining opportunistic infection requiring acute therapy at the time of enrollment.
- •Bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy greater than or equal to Grade 2 at the time of screening.
- •Inability to tolerate oral medication.
- •Any other clinical condition that would preclude compliance with dosing requirements.
- •Patients with the following prior conditions are excluded:
- •History of acute or chronic pancreatitis.
- •Intractable diarrhea (6 or more loose stools/day for more than 7 consecutive days) within 30 days prior to study entry.
- •Proven or suspected acute hepatitis within 30 days prior to study entry.
- •1. Potent neurotoxic drugs, such as vincristine and thalidomide.
- •Other anti-HIV therapy.
- •1. Prophylaxis for pneumocystis carinii pneumonia (PCP) is strongly recommended for patients with CD4 cell counts less than or equal to 200/mm3 or who have had a prior episode of PCP.
- •Immunizations recommended by ACIP for routine practice.
- •Erythropoietin and G-CSF are allowed if myelosuppression emerges on study.
- •1. Any antiretroviral therapy.
- •Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.
- •1. Any prior antiretroviral therapy.
- •Agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study entry.
- •Active alcohol or substance abuse that would prevent adequate compliance or would increase the risk of pancreatitis.
研究者
研究点 (13)
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