Phase I Trial of S-1153 in Patients With HIV Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
To assess the toxicity profile and determine the maximum tolerated dose (MTD), if possible, of S-1153 administered orally 3 times daily for 14 days. To investigate the clinical pharmacokinetic parameters for S-1153. To assess anti-HIV activity associated with S-1153 administration through evaluation of CD4 and viral load measurements.
详细描述
Two separate schedules of S-1153 are administered on this study: single dose (2 dose levels/cohorts) and repeated dose administration over 14 days (escalation through 4 dose levels/cohorts). All doses are determined by body weight.
Single-dose study (Cohort 1):
(4 patients) low-dose po, following a standardized morning meal. (4 patients) low-dose po, fasting.
Single-dose study (Cohort 2), administered during the first 3 levels of the repeated dose study and prior to the initiation of the 4th repeated dose level:
(4 patients): intermediate-dose po, following a standardized morning meal. (4 patients): intermediate-dose po, fasted. Following treatment with S-1153, all single-dose patients (Cohorts 1and 2) are observed for 21 days.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •1. Required for patients with CD4 cell count lower than 200:
- •PCP prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, mepron, or dapsone.
- •Continuation on an approved antiretroviral agent other than non-nucleoside reverse transcriptase inhibitors (e.g., Nevirapine) or other specifically excluded prior medications, if received without complications for at least 4 weeks prior to study entry.
- •Patients must have:
- •Serologically documented HIV infection.
- •Single-dose patients:
- •CD4 cell count greater than 50 (no upper limit for single-dose cohorts). Repeated-dose patients:
- •CD4 count from 50 to 500 within 35 days prior to entrance on study.
- •No active opportunistic infection.
- •Prior Medication:
- •Allowed for entry onto multiple-dose study:
- •Single-dose portion of S-1153 study, provided all study visits and evaluations are completed, all eligibility criteria are met, and a minimum of 30 days has elapsed before Day 1 of the repeated-dose administration.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Active opportunistic infection.
- •Concurrent Medication:
- •Concomitant use (within 5 half-lives prior to administration and for at least 24 hours following cessation of treatment with S-1153) of highly plasma-bound drugs with narrow therapeutic indices, including but not limited to coumadin and dilantin.
- •Prior Medication:
- •1. Investigational new drugs.
- •Excluded within 30 days prior to study entry:
- •Chronic (greater than 7 days) use of drugs known to affect or be extensively metabolized by cytochromes P450, including but not limited to ketoconazole, fluconazole, itraconazole, isoniazid, rifampin, rifabutin, astemizole, terfenadine, or protease inhibitors.
- •Prior Treatment:
- •Excluded within 3 weeks prior to study entry:
- •Cytotoxic chemotherapy.
- •Interferon treatment.
- •Radiation therapy.