HIV Prevention Trials Network Leadership and Operations Center

项目总结 艾滋病毒预防试验网络(HPTN)的首要目标是确定可接受、可行、安全、 有效和可扩展的艾滋病毒预防干预措施，满足美国高危人群的需求。 以及在世界各地。HPTN将通过确定：1)新的生物医学产品和工具来实现这一目标 艾滋病毒预防具有独特的特点，例如更长的行动持续时间，抑制艾滋病毒的新目标 艾滋病毒复制，或作为多用途预防技术(MPTS)；和(2)优化 使用经证明有效的预防干预措施和针对特定风险人群量身定做的新工具 实现对公共卫生的最大影响。这些干预措施将在艾滋病毒优先人群中进行评估 预防包括撒哈拉以南非洲的妇女、处于危险中的青年男女、与 男性(MSM)、与男性发生性关系的变性人(TGW)、女性性工作者(FSW)和 注射毒品(PWID)。这项研究的具体目标是：1)设计和开展长效作用的研究 用于暴露前预防(PrEP)的抗逆转录病毒(ARV)制剂和递送系统；2)设计和 开展研究以评估同时预防艾滋病毒和怀孕、性传播感染的MPTS (性传播感染)或阿片依赖；3)与艾滋病毒疫苗试验合作设计和进行研究 用于评估PrEP的广谱中和抗体(BNAbs)的网络，单独和组合；4)设计 并实施预防艾滋病毒的综合战略。对于前三个目标，HPTN将使用顺序 评价新的预防候选药物的多阶段药物开发战略。第一阶段和第二阶段 将对该制剂(S)的适当剂量、安全性和耐受性进行评价研究。这个 最有希望的系统性药物将使用有利的目标产品概况的标准来推进 新的药物，包括对艾滋病毒的高效和持久的保护，最小的不良反应和药物 互动，高水平的用户接受度，以及对病毒抵抗力的高障碍。有效的生物医学 预防干预措施将被纳入综合战略研究设计，其中还包括 针对艾滋病毒预防的必要性和特定人群的背景需求而量身定做的行为干预 面临艾滋病毒感染风险的人群。社会行为研究(SBR)将是所有人成功不可或缺的一部分 拟议的HPTN艾滋病毒预防议程的各个方面。支持性SBR将用于加强生物医学 HIV产品开发(即告知用户偏好并最终为1-3期临床提供产品设计 试验)，而综合SBR将在设计和适应行为和 在综合战略研究中补充生物医学干预的结构性干预措施。HPTN将 通过与其科学领导、研究团队、 社区合作伙伴、研究参与者、制药公司和资助者。

PROJECT SUMMARY The overarching goal of the HIV Prevention Trials Network (HPTN) is to identify acceptable, feasible, safe, effective and scalable interventions for HIV prevention that address the needs of populations at risk in the U.S. and around the world. The HPTN will address this goal by identifying: 1) new biomedical products and tools for HIV prevention that have unique characteristics, such as longer duration of action, new targets for inhibition of HIV replication, or as multipurpose prevention technologies (MPTs); and (2) integrated strategies that optimize use of proven efficacious prevention interventions and new tools tailored to specific populations at risk to achieve maximal public health impact. These interventions will be evaluated in priority populations for HIV prevention including women in sub-Saharan Africa, young men and women at risk, men who have sex with men (MSM), transgender women (TGW) who have sex with men, female sex workers (FSW) and persons who inject drugs (PWID). The specific aims of this research will be 1) To design and conduct studies of long-acting antiretroviral (ARV) agents and delivery systems for pre-exposure prophylaxis (PrEP); 2) To design and conduct studies to evaluate MPTs that concurrently prevent HIV and pregnancy, sexually transmitted infections (STIs) or opioid dependence; 3) To design and conduct studies in collaboration with the HIV Vaccine Trials Network to evaluate broadly neutralizing antibodies (bnAbs), alone and in combination, for PrEP; 4) To design and conduct integrated strategies for HIV prevention. For the first three aims, the HPTN will use a sequential multi-phase drug development strategy for the evaluation of new candidates for prevention. Phase 1 and 2 studies will be conducted for the evaluation of appropriate dose, safety and tolerability of the agent(s). The most promising systemic agents will be advanced using the criteria for a favorable target product profile for new agents including highly effective and durable protection against HIV, minimal adverse effects and drug interactions, high levels of user acceptability, and a high barrier to viral resistance. Efficacious biomedical prevention interventions will be incorporated into integrated strategy study designs that also include socio- behavioral interventions tailored to the HIV prevention imperatives and contextual needs of the specific populations at risk for HIV infection. Socio-Behavioral research (SBR) will be integral to the success of all aspects of the proposed HPTN HIV prevention agenda. Supportive SBR will be used to strengthen biomedical HIV product development (i.e. to inform user preference and ultimately product design for Phase 1-3 clinical trials), while integrative SBR will play a key role in the process of designing and adapting behavioral and structural interventions to complement biomedical interventions in integrated strategy studies. The HPTN will design and conduct the research through collaboration with its scientific leadership, its research teams, community partners, research participants, pharmaceutical companies and funders.