NCT00002111已完成1 期
A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
研究概览
简要总结
To investigate the toxicity, antiviral activity, and pharmacokinetics in HIV-infected patients receiving 16 weeks of oral saquinavir mesylate ( Ro 31-8959 ) at one of two doses.
详细描述
Cohorts of 16 patients receive 1 of 2 doses of Ro 31-8959 for 20 weeks. Administration of the higher dose will proceed only after 2-week safety data for the first eight patients on the lower dose has been reviewed.
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 must have:
- •Documented HIV infection.
- •CD4 count 200 - 500 cells/mm
- •No evidence of viral resistance.
- •HIV RNA quantifiable by PCR.
- •Negativity for HBsAg, HBeAg, and anti-HBc.
- •Fifty percent of patients must have measurable p24 antigen levels (> 31 pg/ml).
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Active opportunistic infection requiring immediate treatment, such as tuberculosis, cytomegalovirus, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
- •Unable to maintain adequate oral intake.
- •Clinically significant vomiting and/or diarrhea.
- •Malignancy, visceral Kaposi's sarcoma, or lymphoma that will require systemic chemotherapy within the next 12 months.
- •Unable to comply with protocol requirements, in the judgment of the investigator.
- •Any grade 3 or worse laboratory or clinical abnormality.
- •Concurrent Medication:
- •Antineoplastic agents.
- •Concomitant or maintenance treatment with excluded experimental drugs and drugs with known nephrotoxic or hepatotoxic potential.
- •Concurrent Treatment:
- •Radiation therapy other than local skin radiation therapy.
- •Patients with the following prior conditions are excluded:
- •Unexplained temperature >= 38.5 C (101.5 F) persisting for 14 days or more within a 30-day period.
- •Unexplained, chronic diarrhea persisting for 14 days or more within a 30-day period.
- •Prior Medication:
- •Prior treatment with an HIV proteinase inhibitor.
- •AZT within 30 days prior to study entry OR lasting more than 1 year.
- •Other antiretroviral therapy (besides AZT) within 30 days prior to study entry OR lasting more than 14 days.
- •Acute therapy for an opportunistic infection within 14 days prior to study entry.
研究者
研究点 (2)
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