NCT00002365已完成1 期
A Randomized, Parallel, Open-Label Phase I Study of LXR015-1 in HIV-Infected Patients
LXR Biotechnology2 个研究点 分布在 1 个国家目标入组 30 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
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
研究概览
简要总结
To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected patients.
详细描述
Patients will be randomized to 1 of 3 doses of oral LXR015-1 for 28 days and patients will be monitored for adverse events for the duration of the study. Patients will continue to be monitored for least 4 weeks after completion of the dosing.
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 cell count less than 200 cells/mm
- •Prior Medication:
- •Acute therapy for opportunistic infections or serious AIDS defining infections must be completed at least 28 days before study entry.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Patients that are unable to take adequate oral intake (i.e. unable to eat 1 or more meals a day because of chronic nausea, emesis, or abdominal/oral/esophageal discomfort).
- •Patients who have severe diarrhea as defined as >= 7 stools per day, or acute diarrhea due to a treatable cause.
- •If the patient has Cryptosporidia, Mycobacterium avium, or Cytomegalovirus that is unresponsive to treatment and has less than 7 stools per day, the patient may participate in this study.
- •Patients who have any severe or life-threatening laboratory or clinical abnormality, or are not expected to live for 8 weeks.
- •Patients who have an active opportunistic infection, including tuberculosis, cryptococcosis, or other serious AIDS defining infections requiring immediate treatment. Acute therapy must be completed at least 28 days before study entry.
- •Patients with unexplained elevated temperature >= 38.5 degrees C that persists for 7 days or more within 14 days before study entry.
- •Patients with malignancy other than squamous or basal carcinomas of the skin. Patients with visceral Kaposi's sarcoma or lymphoma requiring systemic chemotherapy or radiation treatment will be excluded. Patients with Kaposi's of the skin or mucous membranes may enroll in this study.
- •Patients, who in the judgment of the investigator are unable to comply with the protocol.
- •Concurrent Treatment:
- •Radiation therapy.
- •Patients with the following prior condition are excluded:
- •A known history of hypersensitivity reaction to soy protein or soy lecithin. NOTE:
- •This hypersensitivity is identified through medical history, not skin testing.
- •Systemic chemotherapy.
- •Acute therapy for opportunistic infections or other serious AIDS defining infections.
- •Intravenous rehydration as treatment for diarrhea.
- •Patient must be taking a stable regimen (about 8 weeks) of anti-viral, anti-opportunistic infection and/or anti-diarrheal (if patient has diarrhea) medications.
研究者
研究点 (2)
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