NCT00002194已完成1 期
An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.
详细描述
The study is conducted in two separate groups. Patients in Group I receive clarithromycin orally for 32 days and nevirapine orally for 28 days.
Patients in Group II receive erythromycin intravenously on days 0, 14, 28, and 43 and nevirapine orally for 28 days.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Antiretroviral drugs (i.e., zidovudine, zalcitabine, stavudine, lamivudine, didanosine, indinavir, saquinavir) provided that there has been no change in dosing of the medication > 25% within 4 weeks of study entry.
- •Patients must have:
- •HIV positive status.
- •CD4 count >= 100 cells/mm
- •Prior Medication:
- •Patients may be on clarithromycin at study entry.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions are excluded:
- •Malabsorption, severe chronic diarrhea, or inability to maintain adequate oral intake.
- •Concurrent Medication:
- •Macrolide antibiotics (erythromycin, azithromycin, dirithromycin), azole fungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, phenytoin, terfenadine, astemizole, cisapride, triazolam, midazolam, other non-nucleoside reverse transcriptase inhibitors, antibiotics containing clavulanic acid, and Augmentin.
- •Patients with the following prior conditions are excluded:
- •History of drug allergy or known drug hypersensitivity.
- •History of clinically important disease including hepatic, renal, cardiovascular, or gastrointestinal disease.
- •Prior Medication:
- •Investigational drugs or antineoplastic agents within 12 weeks of study entry.
- •Participation in a clinical trial that used ERMBY within one year of study entry.
- •Systemic treatment with drugs known to be potent hepatic enzyme inducers or inhibitors (e.g., oral macrolide antibiotics, azole antifungals, cimetidine, rifampin, rifabutin, and carbamazepine) within 28 days of study entry.
- •Use of protease inhibitors; ritonavir, nelfinavir, indinavir, or non-nucleoside reverse transcriptase inhibitor compounds e.g., delavirdine) within 4 weeks of study entry.
- •Prior Treatment:
- •Radiotherapy within 12 weeks of study entry.
- •Risk Behavior:
- •Current history (within the last year) of IVDA, ETOH, or substance abuse.
研究者
研究点 (1)
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