Merck has terminated a trial comparing once-daily dosing against the currently recommended twice-daily dosing of raltegravir.
The trial involved 770 treatment-naive people. About half took 800 mg of raltegravir once daily, while the other half adhered to the approved dose of 400 mg twice daily. Both groups also received Truvada. At 48 weeks, viral loads were undetectable in 83.2% of the once-daily group versus 88.9% of the twice-daily group.
Both of the doses tested in this study performed well, yielding virologic suppression rates of greater than 80%, but the difference in response put the once-daily approach just outside the protocolA study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment -specified criteria for noninferiority, which was 10%. The fact that a treatment strategy with an 83% success rate ended up being declared insufficient demonstrates the high standards we have today for first-line therapy.
Notably, both the investigational(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. integrase inhibitors elvitegravir (boosted with cobicistat) and S/GSK1349572 are being developed for once daily dosing.