NCT01097070已完成2 期
A Phase II Multicenter, Open-label, Randomized, Parrallel Group Study to Assess the Pharmacokinetics of Bevirimat (BVM) 100 mg Tablets Administered to HIV-1 Positive Patients for 15 Days
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Myrexis Inc.
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Measure bevirimat blood plasma concentrations to calculate the pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life when bevirimat is administered as 2 x 100 mg tablets BID, 3 X 100 mg tablets QD, 4 X 100 mg tablets QD for 15 days
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (behavior in the body) of bevirimat administered for 15 days to HIV-positive individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Have documentation of HIV-1 infection in their medical records (documentation of any prior plasma viremia is acceptable).
- •Have a CD4+ lymphocyte count >/= 100 cells/mm
- •Have a screening plasma HIV-1 RNA value, measured by the Roche Amplicor assay, of <400 copies/mL.
- •Be receiving an ARV therapy regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to screening, and which is to be continued through Day 15 of the study.
- •Be informed of the nature of the study and provide written informed consent.
- •Be legally competent and able to communicate effectively with study personnel.
- •Be able and willing to comply with outpatient visits.
排除标准
- •Presence of any acute illness within 14 days prior to study entry.
- •Presence of any AIDS-related opportunistic infection (Category C according to the CDC Classification System for HIV-1 Infection, 1993 Revised Version) that is unstable in the Investigator's opinion or diagnosed in the 30 days prior to study entry.
- •Patients who are, in the opinion of the Investigator, unable to comply with the dosing schedule and protocol evaluations.
- •Patients with malabsorption syndromes affecting drug absorptions (e.g. Crohn's disease, chronic pancreatitis).
- •Patients with systolic blood pressure < 90 mmHg or > 160 mmHg or diastolic blood pressure < 50 mmHg or > 110 mmHg.
- •A history of seizures (excluding pediatric febrile seizures) or current administration of prophylactic anti-seizure medication for the indication of seizures or seizure-related conditions.
- •A history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA).
- •Patients who have received radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to first dose of study drug.
- •Patients who have received treatment with immunomodulating agents such as IL-2, alpha-interferon, beta-interferon, or gamma-interferon within 4 weeks prior to first dose of study drug.
- •Receipt of an investigational drug or product, or participation in a drug study within a period of 30 days prior to receiving study medication.
- •Bupropion-containing products require at least a 14-day washout period and will not be approved for co-administration.
- •Rifampin or other rifamycin products require at least a 28-day washout period and will not be approved for coadministration.
研究组 & 干预措施
Bevirimat 200 mg twice daily, 15 days
Experimental
干预措施: Bevirimat (Drug)
Bevirimat 300 mg once daily, 15 days
Experimental
干预措施: Bevirimat (Drug)
Bevirimat 400 mg once daily, 15 days
Experimental
干预措施: Bevirimat (Drug)
结局指标
主要结局
Measure bevirimat blood plasma concentrations to calculate the pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life when bevirimat is administered as 2 x 100 mg tablets BID, 3 X 100 mg tablets QD, 4 X 100 mg tablets QD for 15 days
时间窗: 16 days
次要结局
- Measure bevirimat blood plasma concentrations following the administration of bevirimat 2 X 100 mg, 3 x 100 mg, or 4 x 100 mg tablets after a standardized meal. The pharmacokinetic parameters of AUC, Cmax, Cmin, and half-life will be calculated.(Day 15)
研究者
研究点 (4)
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