Developmental Clinical Studies - A Phase I study of a novel peptide fusion inhibitor for the treatment of chronic HIV infection

过去二十年来，在资源丰富的国家，随着有效的抗逆转录病毒（抗艾滋病毒）疗法的发展，感染艾滋病毒的人可以活很多年，由于这一成功，现在出现了与年龄有关的医疗问题，这在所有老龄人口中都是常见的。因此，应对艾滋病毒感染人口老龄化是一种新的医学现象，并提出了新的挑战，包括管理治疗艾滋病毒感染的药物与治疗其他疾病的药物之间的相互作用。这是一个问题，因为目前绝大多数抗艾滋病毒疗法容易与其他药物相互作用。此外，许多目前的抗艾滋病毒疗法都有副作用，这些副作用对老年人来说更成问题，比如增加心脏病发作的风险或胆固醇升高。鉴于这些因素，新的抗逆转录病毒药物没有与其他药物相互作用的倾向，副作用也有所改善，这是一项至关重要的医疗需求。我们开发了一种新的抗逆转录病毒药物，目前被称为C34-PEG4-Chol，它可以阻止HIV病毒进入细胞。虽然需要注射给药，但C34-PEG4-Chol只需要每周给药两次甚至一次，而且副作用可能很小，不会与其他药物相互作用。到目前为止，C34-PEG4-Chol已经在实验室和动物模型中进行了研究。我们建议首次在慢性HIV感染受试者中评估这种新药的安全性和抗HIV活性。该提案将HIV药物的科学和临床专业知识与开发C34-PEG4-Chol的公司结合起来，该研究将在英国注册的试验单位进行。这种新型抗逆转录病毒药物有潜力提供一种低毒性、易于施用的抗逆转录病毒药物，作为未来有效抗逆转录病毒治疗的一部分，避免了目前许可药物的治疗限制性毒性。

With the development of effective antiretroviral (anti-HIV) therapy over the last two decades, in resource rich countries, individuals with HIV infection can live for many years and as a consequence of this success, are now developing age related medical problems as seen in all ageing populations.Dealing with an ageing HIV infected population is therefore a new medical phenomenon and poses new challenges including managing interactions between medication to treat HIV infection and medication to treat other medical conditions. This is problematic as the vast majority of current anti-HIV therapies are prone to interactions with other medications. Also, many current anti-HIV therapies have side effects which are more problematic in older individuals such as increasing risk of heart attacks or rises in cholesterol. Given these factors, new antiretroviral agents without the propensity to interact with other medication and with improved side effect profiles represent a crucial medical need.We have developed a new antiretroviral drug, currently known as C34-PEG4-Chol, which prevents the HIV virus from entering cells. Although required to be given by injection, C34-PEG4-Chol only requires to be given twice or even once weekly and is likely to have minimal side effects with no interactions with other medicines. To date, C34-PEG4-Chol has been studied in the laboratory and in animal models. We propose to assess the safety and anti-HIV activity of this new agent in subjects with chronic HIV infection for the first time.This proposal brings together scientific and clinical expertise in HIV medicine with the company who have developed C34-PEG4-Chol and the study will be conducted within a registered UK trials unit. This novel antiretroviral agent has the potential to offer a low toxicity, easily administered, antiretroviral agent as part of effective antiretroviral therapy for the future avoiding the treatment limiting toxicities of current licensed agents.