A new study will examine whether a concentrated version of an experimental drug can prevent HIV infection with less frequent treatment. Oregon Health & Science University (OHSU) is leading the five-year, $3-million study (https://projectreporter.nih.gov/project_info_description.cfm?aid=10064937&icde=51039701&ddparam=&ddvalue=&ddsub=&cr=6&csb=default&cs=ASC&pball=) to explore if a new formulation of the drug leronlimab can prevent infection of the monkey version of HIV in rhesus macaques. If the new formulation works, the injectable drug could potentially be taken every three months instead of weekly, as is recommended with the drug’s current design. Jonah Sacha, PhD, a Professor at OHSU’s Oregon National Primate Center and Vaccine & Gene Therapy Institute, is leading the study. Leronlimab is a monoclonal antibody that blocks HIV from entering immune cells through a surface protein called CCR5. Following a Phase 3 clinical trial, Vancouver, Washington-based biotechnology firm CytoDyn is seeking FDA approval to use their current formula of leronlimab to treat humans infected with HIV. Clinical trials to evaluate leronlimab’s use for pre-exposure prophylaxis, or PrEP, to prevent human infection from the virus that causes AIDS are also planned. Some PrEP drugs are already available, but they can lead to adverse side effects such as liver, heart, and bone problems, and some people are resistant to them. Existing PrEP options typically require frequent use, such as taking a pill daily or must be given at a clinic. Leronlimab is designed to be a self-administered injection. This study will evaluate concentrated microparticle formulations of leronlimab that are designed to last longer and be delivered through a single injection.
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