A Randomised, Open-Label, Comparative Study of Itraconazole vs. Amphotericin B for the Induction Therapy of Penicilliosi

青霉菌病是亚洲人类免疫缺陷病毒（HIV）感染者中最常见和危及生命的感染之一。尽管亚洲感染艾滋病毒的人数迅速增长，但世界上有一半以上的人感染了艾滋病毒？但目前还没有任何临床试验来评价青霉菌病的治疗方法。目前的国际指南建议用两性霉素B治疗2周，然后用伊曲康唑治疗10周。本指南基于一项没有比较组的观察性研究，通常被认为是医学上的弱证据。此外，两性霉素B要么无法获得，要么只在亚洲的一些主要三级保健中心提供，只能通过静脉每天输液6小时以上，有许多副作用，例如在越南，2周的治疗费用平均约为患者月薪的5倍。另一方面，伊曲康唑似乎是一种很好的替代药物，在各省和区诊所的当地药房广泛可得，可口服，通常耐受性良好，价格仅为两性霉素b的一小部分。香港和印度提示伊曲康唑可能与两性霉素b具有相似的治疗效果。因此我们将进行临床试验，比较伊曲康唑与两性霉素治疗青霉菌病的相对疗效。总共440名诊断为青霉菌病的成年人将被邀请参加这项研究，并将在治疗的前两周随机分配到伊曲康唑或两性霉素B组。将在2周和6个月结束时比较两个治疗组的生存率。这将是治疗青霉菌病的里程碑式研究。研究结果将改变或支持目前的国家和国际青霉菌病治疗指南。如果研究人员是正确的，伊曲康唑被证明至少与两性霉素B一样有效，但更便宜，耐受性更好，更容易管理，那么伊曲康唑代表了青霉菌病患者更好的治疗选择，同时为患者和卫生保健系统节省了大量成本。如果研究人员是正确的，那么伊曲康唑可以立即给予当地省级和地区诊所的患者，确保患者的早期治疗和更好的结果。

Penicilliosis is one of the most common and life-threatening infections in people infected with Human Immunodeficiency Virus (HIV) in Asia. Despite the fast growing numbers of people infected with HIV in Asia where over one half of the world?s population lives, there has not been any clinical trials to evaluate the treatment of penicilliosis. The current international guideline recommends treatment with amphotericin B for 2 weeks followed by itraconazole for 10 weeks. This guideline is based on one observational study without a comparator group and is generally considered weak evidence in medicine. Further, amphotericin B is either unavailable or available in only selected major tertiary care centres in Asia, can only be given through a vein daily over 6 hours of infusion, has many side effects, and a 2 week treatment in Viet Nam for example would cost an average patient approximately 5 times his monthly salary . Itraconazole, on the other hand, appears to be a good alternative drug that is widely available in local pharmacies in the provinces and district clinics, can be given by mouth, is generally well tolerated, and costs a fraction of the price of amphotericin B. Available data from Viet Nam, Thailand, Hong Kong and India suggest that itraconazole may have similar treatment efficacy compared to amphotericin B. Therefore we will conduct a clinical trial comparing the relative effectiveness of itraconazole versus amphotericin in the treatment of penicilliosis. A total of 440 adults who are diagnosed with penicilliosis will be invited to participate in the study and will be randomly assigned to either itraconazole or amphotericin B during the first 2 week of therapy. Survival rates will be compared in the 2 treatment arms at the end of 2 weeks and in 6 months. This will be the landmark study for treatment of penicilliosis. The results will either change or support the current national and international guidelines for treatment of penicilliosis. If the investigators are correct, that itraconazole is proven to be at least as effective as amphotericin B, but is much cheaper, better tolerated, and easier to administer, then itraconazole represents a better treatment choice for the patients with penicilliosis while saving significant costs for the patients and the health care system. If the investigators are correct, then itraconazole can be given immediately for patients in the local provincial and district clinics, ensuring earlier treatment and better outcomes for patients.