Clinical trials for intiviral in general Essay Example | Topics and Well Written Essays - 500 words

Clinical trials for intiviral in general - Essay Example After the promising drug has been identified based on its mode of action on the target , it undergoes a thorough pre-clinical testing involving biological test-tube and animal studies. The primary goal is to determine the safety of the product for initial use in humans, and if the drug shows pharmacological activity that justifies commercial development. These studies will show if the test drug works against its viral target. In the case of HIV, after it was reported that diketo acids can inhibit strand transfer step (3), studies were used to exhibit the disease progression and test treatments in macaque monkeys (4). Animal studies have utilized the simian immunodeficiency virus (SIV) to study acquired immunodeficiency in primates, however, SIV shares only 50% homology to HIV. Recently, a genetically altered HIV can infect rhesus monkeys in such a way that the resulting infection mimics the early stages of HIV human infection (5). Successful pre-clinical trials pave the way for a drug company to file an Investigational New Drug application. The application will include data on animal pharmacology and toxicological studies, manufacturing information, the protocols for the clinical trials, and the information about the investigators. The investigators and sponsors are responsible for the protection of the clinical trial subjects (6). Drugs have to be subjected to several phase of clinical trials for them to be approved for marketing. Phase I trials are meant to determine the metabolic and pharmacological actions, and the maximum tolerable dose of the drug in 20 to 80 volunteers. The trial normally lasts for a minimum of one month to a year. Measured outcomes are vital signs, virus plasma and serum levels and adverse events or reactions to the drug. Trials are unblinded and do not employ controls (7), although blinding and controls can be used to improve the validity. Phase I trials usually do not have therapeutic objectives, and may be conducted in