NCT00002440已完成2 期
An Open-Label, Phase II Trial to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of 1592U89 in Combination With Selected HIV-1 Protease Inhibitors in Antiretroviral-Naive, HIV-1-Infected Patients.
Glaxo Wellcome15 个研究点 分布在 1 个国家目标入组 80 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
- 80
- 试验地点
- 15
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.
详细描述
In this Phase II, open-label study patients (16 per treatment group) are randomized to receive 1592U89 in combination with one of five protease inhibitors: indinavir, saquinavir, ritonavir, nelfinavir, or 141W94 for up to 48 weeks.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Local treatment for Kaposi's sarcoma.
- •GM-CSF, G-CSF or erythropoietin.
- •Patients must have:
- •HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture.
- •CD4+ cell count >= 100 cells/mm3 within 14 days of study drug administration.
- •HIV-1 RNA >= 5,000 copies/ml within 14 days of study drug administration.
- •No active or ongoing AIDS-defining opportunistic infection or disease.
- •Signed, informed consent from parent or legal guardian for patients less than 18 years of age.
- •Prior Medication:
- •Local treatment for Kaposi's sarcoma.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication.
- •Life-threatening infection or other serious medical condition that may compromise a patient's safety.
- •Concurrent Medication:
- •Other investigational agents. NOTE:
- •Those available through Treatment IND or expanded access programs are evaluated individually.
- •Chemotherapeutic agents for the initial 24 weeks of study (except local treatment for Kaposi's sarcoma).
- •Agents with documented anti-HIV activity in vitro.
- •Foscarnet.
- •Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons.
- •Antioxidants.
- •Concurrent Treatment:
- •Radiation therapy within the first 24 weeks of study.
- •Patients with the following prior conditions are excluded:
- •History of clinically relevant pancreatitis or hepatitis within the last 6 months.
- •Participation in an investigational HIV-1 vaccine trial.
- •Prior Medication:
- •Antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy.
- •Cytotoxic chemotherapeutic agents within 30 days of study drug administration.
- •HIV-1 vaccine dose within the 3 months prior to study drug administration.
- •Immunomodulating agents, such as systemic corticosteroids, interleukins or interferons within 30 days of study drug administration.
- •Prior Treatment:
- •Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.
研究者
研究点 (15)
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