Multicenter, Rising, Multiple-Dose, Placebo-Controlled, Dose-Response Study to Evaluate the Safety, Tolerability, and Anti-Viral Activity of 4 Weeks of Treatment With 200-800 Mg Fozivudine Tidoxil in Patients With HIV-1 Infection (MF4314).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
To identify doses of fozivudine tidoxil that are well tolerated and produce measurable antiviral activity.
To identify the adverse event profile that defines the maximum tolerated dose. To characterize the single- and multiple-dose pharmacokinetics of fozivudine and its metabolites.
To correlate the adverse event profile and antiviral activity of fozivudine with pharmacokinetic parameters.
详细描述
In this double-blind, dose-escalating study, patients receive fozivudine tidoxil at one of 5 dosage levels for 4 weeks and are randomized with respect to once- or twice-daily administration (cohorts 2 vs. 3 and 4 vs. 5). Within each cohort, 10 patients are randomized to the study drug and 2 to the placebo. At least 9 of the 12 patients enrolled in Cohort 1 must complete the entire 4-week course before Cohorts 2 and 3 are enrolled. At least 18 of these 24 patients must complete 2 weeks of the 4-week course before Cohorts 4 and 5 are enrolled.
研究设计
- 研究类型
- Interventional
- 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
- •Concurrent Medication:
- •Primary and secondary prophylaxis for opportunistic infection if stable and initiated at least 3 months prior to study drug administration.
- •Patients must have:
- •HIV-positive status.
- •One HIV RNA count > 10,000 copies/ml within 30 days prior to entry, with a second count at least 3-fold above or below the first value.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Active medical problems including chronic diarrhea and active opportunistic infections such as cryptococcosis, Pneumocystis carinii, histoplasmosis, etc..
- •Malignancy for which systemic therapy or radiation therapy is expected to be required during the study.
- •Any other disease or condition that would place a patient at undue risk or confound the results of the study.
- •Concurrent Medication:
- •Systemic therapy for malignancy.
- •Prior Medication:
- •Zidovudine or any other nucleoside reverse transcriptase inhibitor.
- •Immunomodulators within one month prior to study drug administration.
- •Investigational drugs within 30 days prior to study drug administration.
- •Systemic cytotoxic chemotherapy within 3 months prior to study drug administration.
- •Prior Treatment:
- •Extended-field radiation therapy within 3 months prior to study drug administration.
- •Blood transfusion within 2 weeks prior to study drug administration.