Beacon NewsFlashes – December 2, 2010
Merck Halts Clinical Trial Of Once-Daily Isentress Dosing – Merck has halted a Phase 3 clinical trial that failed to show that once-daily dosing of Isentress (raltegravir) is as effective as twice-daily dosing in treatment-naïve patients. Results of the clinical trial showed that after 48 weeks, 83 percent of study participants taking Isentress once daily achieved viral suppression (undetectable amount of virus in the blood) versus 89 percent of participants who took Isentress twice daily. As a result, Merck has decided to halt the clinical trial and switch all trial participants to twice-daily Isentress dosing. For more information, please see the Merck press release.
FDA Approves BioLytical Laboratories 60 Second HIV Test – The U.S. Food and Drug Administration (FDA) announced yesterday that it has approved a new HIV test, called the INSTI HIV-1 Antibody Test, that can give results in 60 seconds. Previous rapid HIV tests gave results within about 10 to 20 minutes. BioLytical Laboratories, the Canadian-based manufacturer of the test, has also applied for a Clinical Laboratory Improvement Amendment waiver from the FDA, which, if granted, would allow users to administer the test themselves at home. The INSTI Test has been available in Canada and internationally since 2006; bioLytical Laboratories filed for approval in the U.S. in June 2009. For more information, please see the press release at the bioLytical Laboratories website.
Study Indicates Switching From Sustiva To Intelence May Help Reduce Side Effects In The Central Nervous System – Results of a small study indicate that people who suffer from side effects related to the central nervous system when taking Sustiva (efavirenz) may experience fewer problems by switching to Intelence (etravirine). The study of 38 men found that after 12 weeks, men who switched to Intelence experienced fewer bouts of insomnia, abnormal dreams, and nervousness. All participants successfully maintained viral suppression. Sustiva and Intelence are both nucleoside reverse transcriptase inhibitors, and both are recommended as components of an initial antiretroviral regimen for treating HIV. For more information, please see the study in the journal AIDS (abstract).
Related Articles:
- Second Clinical Trial Shows Long-Term Efficacy Of Isentress In People With HIV
- Clinical Trial Shows Sustained Response To Isentress In People With HIV (IAS 2011)
- Switching Anti-HIV Therapy From Sustiva To Intelence May Help Reduce Neurological Side Effects
- Beacon NewsFlashes – December 27, 2010
- Study Confirms That Intelence Is Effective In People With Drug-Resistant HIV