An experimental [1](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 antiviral [2]A 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 II [3]A 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. study 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 resistance [4]HIV 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.
Links:
[1] http://www.napwa.org.au/glossary/term/491
[2] http://www.napwa.org.au/glossary/term/123
[3] http://www.napwa.org.au/glossary/term/91
[4] http://www.napwa.org.au/glossary/term/109