EUCTR2011-005581-37-GB进行中（未招募）1 期
Efficacy of Switch to Lopinavir/Ritonavir in Improving Cognitive function in Efavirenz treated patients - SLICE Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Documented HIV-1 RNA viral load (VL) measurement of <50 copies/ml within the 4 months preceding study entry and no VL exceeding 200c/ml within 1 year prior to study entry. This constraint is to remove any CNS effects of active viral replication at baseline, and / or potential change in level of viral replication during the study period
- •On HAART (at least 3 anti-retroviral drugs from at least 2 classes) for at least 12 months prior to study entry
- •On Efavirenz (EFV, Sustiva) for at least 6 months prior to study entry. This constraint is to remove acute neuropsychiatric effects of EFV which are typically clinically apparent in the first 4-6 weeks of therapy
- •Patient has provided written informed consent for participation in the study prior to any study specific procedures
- •Age 18 to 65 years inclusive
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Use of Kaletra or any other HIV protease inhibitor within 6 months of study entry
- •Current self-reported (within last 3 months) recreational drug use
- •Current self-reported weekly alcohol consumption exceeding 35 units / week
- •Known contra-indication to MRI scanning
- •Known hypersensitivity to Kaletra, or to ritonavir in pharmacokinetic boosting doses (100 or 200mg Ritonavir daily)
- •Currently (within 6 weeks of study entry) receiving interferon therapy for treatment of chronic viral hepatitis, or expected to commence such treatment with the next 4 months
- •Severe renal or hepatic impairment
- •Pregnancy, or women planning to become pregnant within next 6 months
- •breastfeeding
- •Use of other investigational study drugs within 30 days prior to study entry (defined as date of randomisation into study)
- •Patients on drugs that will interact with Efavirenz and should not be co-administered including: Terfenadine, Astemizole, Cisapride, Midazolam, Triazolam, Pimozide, Bepridil, or ergot alkaloids (for example, Ergotamine, Dihydroergotamine, Ergonovine and Methylergonovine) because competition for CYP3A4 by Efavirenz could result in inhibition of metabolism and create the potential for serious and/or life-threatening undesirable effects (for example, cardiac arrhythmias, prolonged sedation or respiratory depression), herbal preparations containing St. John's wort (Hypericum perforatum).
- •Patients on drugs that will interact with Kaletra and should not be co-administered including: Terfenadine, Astemizole, Cisapride, Midazolam, Triazolam, Pimozide, Alfuzosin, Amiodarone, Fusidic Acid, Dihydroergotamine, Ergonovine, Ergotamine, Methylergonovine, Lovastatin, Simvastatin Sildenafil, Vardenafil, herbal preparations containing St. John's wort (Hypericum perforatum), Rivaroxaban.
- •Previous participation in this study
研究者
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