An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE® ) and Ethinyl Estradiol/Norethindrone [ORTHO-NOVUM® 1/35 (21 Pack)] in HIV-1 Infected Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Tmax (Time of maximum concentration) of EE/NET
研究概览
简要总结
Study to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl estradiol (EE)/norethindrone (NET).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients between the ages of 18 and 65 years
- •Plasma HIV-1 RNA <= 400 copies/mL, documenting HIV-1 infection, within 28 days prior to Study Day 0
- •Lymphocytes Expressing CD4+ Surface Marker (CD4+ cell count) >= 100 cells/mm³ within 28 days prior to Study Day 0
- •Patients who meet the following laboratory parameter:
- •Lymphocyte count >= 1000 cells/mm³
- •Hemoglobin >= 9.0 g/dl (men and women)
- •Platelet count >= 75000 cells/mm3
- •Alkaline Phosphatase <= 3.0 times the upper limit of normal
- •Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) <= 3.0 times the upper limit of normal
- •Total bilirubin <= 1.5 times the upper limit of normal
- •Creatinine <= 2mg/dL
- •Female patients of reproductive potential must be willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream or jelly, or condoms with spermicidal foam)
- •Patients who are informed of and willing and able to comply with the investigational nature of the study and had signed a written consent in accordance with institutional and federal guidelines
- •Patients who have been on stable antiretroviral therapy (no changes in medication or dose) for at least thirty days prior to study entry and who will continue on background during study participation
排除标准
- •Female patients who are pregnant or breast-feeding
- •Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of stud entry (Study Day 0). Such substances in these categories include: macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole) rifampin, rifabutin, and phenytoin
- •Patients receiving any investigational drug within 30 days of the first dose of study medication and any antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
- •Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
- •Patients with a history of intravenous drug abuse, alcohol or substance abuse considered by the Investigator and Boehringer Ingelheim Pharmaceutical Incorporated (BIPI) Medical Monitor to be a significant impairment to health and compliance
- •Patients undergoing treatment for an active infection
- •Patients with hepatic insufficiency due to cirrhosis
- •Patients with renal insufficiency
- •Patients who are heavy smokers (e.g. > 20 cigarettes per day)
- •Patients currently taking Norvir® (Ritonavir) or Rescriptor® (Delavirdine)
研究组 & 干预措施
Nevirapine tablets
once a day (q.d.) Day 2-15,
twice a day (b.i.d.) Study day 16-30
干预措施: Nevirapine (Drug)
EE/NET tablets
Single dose on Study Day 0 and 30
干预措施: EE/NET (Drug)
结局指标
主要结局
Tmax (Time of maximum concentration) of EE/NET
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
AUCss (Area under the concentration time curve at steady state) of nevirapine
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Cmin (minimum observed concentration) of nevirapine
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Cmax (maximum observed concentration) of nevirapine
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
AUC (Area under the plasma concentration time curve) of ethinyl estradiol/norethindrone (EE/NET)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
Cmax (maximum observed concentration) of EE/NET
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
Cl/F (Oral clearance) of nevirapine
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
次要结局
- Number of patients with adverse events(up to 59 days)