NextGen 针对艾滋病毒儿童的长效靶向组合 ART-猫眼课题宝

NextGen 针对艾滋病毒儿童的长效靶向组合 ART

批准号：

10610951

负责人：

RODNEY J.Y. HO

金额：

$142.45万

依托单位：

UNIVERSITY OF WASHINGTON

依托单位国家：

美国

项目类别：

财政年份：

2020

资助国家：

美国

项目状态：

未结题

起止时间：

2020-04-06 至 2026-03-31

来源：

https://reporter.nih.gov/project-details/10610951

关键词：

Abbreviations Acceleration Adherence Adolescent Adult Anti-Retroviral Agents Blood Cells Child Childhood Clinical Clinical Paths Combination Drug Therapy Combined Modality Therapy Communication Data Data Set Deglutition Development Development Plans Disease Dosage Forms Dose Drug Combinations Drug Kinetics Drug Targeting Ensure Evaluation Exhibits FDA approved Fatigue Formulation Funding Generic Drugs HIV HIV Integrase HIV Protease Human body Injectable Integrase Integrase Inhibitors Investigational Drugs Lead Lopinavir Lopinavir/Ritonavir Marketing Modeling National Institute of Allergy and Infectious Disease Oral Pharmaceutical Preparations Phase Plasma Primates Process Proteins RNA-Directed DNA Polymerase Recommendation Research Resources Ritonavir Route Safety Schedule Source Specific qualifier value Suspensions Technology Tenofovir Testing Therapeutic Time Tissues United States Food and Drug Administration United States National Institutes of Health Update Validation Viral Water Work anti-viral efficacy antiretroviral therapy clinical development combat drug action first-in-human industry partner innovation interest large scale production meetings nano nanoparticle nanotechnology platform nonhuman primate novel drug combination oral HIV pediatric human immunodeficiency virus pharmacokinetic model physiologically based pharmacokinetics pill preclinical development preference programs public-private partnership research and development safety study simian human immunodeficiency virus success technology platform timeline

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ABSTRACT The Targeted, Long-acting and Combination Anti-Retroviral Therapeutic (TLC-ART) Program has developed a scalable, drug-combination nano-platform technology called DcNPs (drug combination nanoparticles) that enables the stabilizing of insoluble and soluble short-acting antiretroviral drugs together in an injectable suspension. In nonhuman primates, DcNP is able to transform short-acting oral HIV-drug combinations into long-acting combinations that can be detected in plasma and cells with no lag phase (i.e., rapid peak drug concentrations). This application plans to leverage the novel DcNP technology to develop a safe and effective long-acting combination antiretroviral therapy for children with HIV. A long-acting injectable is urgently needed for children who struggle with adherence issues, including pill fatigue or an inability to swallow. We have established a public-private partnership for the most advanced two active drug TLC-ART platform evaluation intended for adult treatment through UM1 funding from the NIH. With these invaluable resources, we plan to create a long-acting monthly injectable formulation for children that includes three active drugs targeted to two HIV proteins. Our set of milestone-driven aims is based on a defined target product profile (TPP), and will be guided by an external advisory board (EAB) through scheduled and on-demand meetings. The research-focused objectives (Aims 1 and 2) are intended to evaluate a set of four different potential pediatric HIV-drug DcNP combinations and to select a candidate based on studies in juvenile non-human primates to progress to pre-clinical development and seek FDA guidance for an accelerated clinical progression plan (Aims 3-6). The five-year proposal will have EAB and NIAID/DAIDS program oversight to ensure success, and the study results will form a basis to develop safe and effective long-acting antiviral combinations for treatment of young children with HIV.

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