Date: 2015-02-09
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: BMS (USA - NY)
Product: BMS-663068 (fostemsavir)
Action
mechanism: HIV attachment inhibitor. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.
Disease: HIV/AIDS
Therapeutic area: Infectious diseases
Country: Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, France, Germany, Greece, Ireland, Italy, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Taiwan, UK, USA
Trial
details: This multi-arm phase 3 randomized placebo controlled double blind clinical trial investigates the efficacy and safety of BMS-663068 in heavily treatment experienced subjects infected with multi-drug resistant HIV-1. The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance. (NCT02362503)
Latest
news: This phase III trial in heavily treatment-experienced patients (defined as individuals who can no longer formulate a viable three-drug treatment regimen due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications) began in February 2015 and is ongoing.
