NAPWA

An experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. NNRTI, RDEA806, appeared to have strong antiviralA medication or substance which is active against one or more viruses. May include anti-HIV drugs, but these are more accurately termed antiretrovirals. activity and a favourable safety profile in a Phase IIA smaller clinical trial designed to establish whether a drug is effective. Phase II studies are conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. If there is evidence that the drug is effective, a Phase III study is undertaken, with a larger number of participaants, to confirm this. studyA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. presented at IAS 2008. HIV-positive patients, starting treatment for the first time, who took the NNRTI as monotherapy were reported to have a high barrier to drug resistanceHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant.. Further studies involving HIV-negative subjects showed that RDEA806 was well tolerated at single doses up to 800mg, as well as multiple doses up to 1000 mg per day for two weeks. No evidence of central nervous system side-effects or rash were seen in these studies. The presenter Dr Graeme Moyle concluded by saying that, in these early studies, RDEA806 was “well tolerated with antiviral effect across all doses.”

Moyle G, et. Al. Antiviral activity of RDEA806, a novel HIV non-nucleoside reverse transcriptase inhibitor, in treatment of naive HIV patients. 17th International AIDS Conference, Mexico City. Abstract THAB0402, 2008.