NAPWA

Follow-up results from 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. study of rilpivirine (TMC-278), Tibotec’s 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. next generation NNRTI were presented at IAS 2008. The 96-week data indicate that when combined with Truvada or Combivir, rilpivirine has comparable results to the leading NNRTI, efavirenz.

A significantly lower incidence of rashes, central nervous system effects – such as dizziness, drowsiness, vertigo, abnormal dreams and nightmares – was seen among those taking rilpivirine compared with efavirenz. There were also smaller increases in triglycerides and cholesterolAn essential component of cell membranes and nerve fibre insulation, cholesterol is important for the metabolism and transport of fatty acids and the production of hormones and Vitamin D. Cholesterol is manufactured by the liver, and is also present in certain foods. High blood cholesterol levels have been linked to heart disease and may be a side effect of some anti-HIV medications. in the rilpivirine group.

Of possible concern were abnormal heart rhythm measurements determined by electrocardiograph (ECG) – seen in some patients treated with rilpivirine in the study. It was reported that it was most often seen in patients who also took Combivir. Abnormal ECG measurements were least pronounced in the 25 milligrams of rilpivirine dosing group – the dose Tibotec plans to study more closely in Phase IIIA large clinical trial designed to establish whether a drug is effective and safe enough for widespread use. Phase III studies include expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. clinical trials.

Santoscoy M, et. al. TMC278 (rilpivirine), a next generation NNRTI, demonstrates long-term efficacy(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. and tolerability in ARVA medication or other substance which is active against retroviruses such as HIV.-naive patients: 96 week results of study C204. International AIDS Conference. Mexico City. Abstract TUAB0103, 2008.