terça-feira, janeiro 24, 2006
Pfizer pára braço QD do maraviroc em naives
Comunicado da Pfizer:
January 24, 2006
DSMB Recommends continuation of maraviroc phase 3 development program
Treatment naive program continues with maraviroc twice daily dose;
Treatment-experienced program continues unchanged with once and twice daily dosing arms
Pfizer reported that the independent Data Safety Monitoring Board (DSMB) for maraviroc, Pfizer’s CCR5 antagonist in development for the treatment of HIV, met in January 2006 as part of their scheduled review of the phase 2b/3 development program. The maraviroc DSMB is an independent group of experts who specialize in the treatment of patients with HIV/AIDS and includes representatives from global regions where maraviroc studies are underway. The ongoing review of data by the DSMB helps to ensure the safety of patients participating in the studies.
The DSMB recommended that the three Phase 2b/3 clinical studies for the investigational drug in treatment-experienced patients continue as currently designed. They also recommended that Pfizer discontinue the maraviroc 300 mg once-daily dosing arm in the treatment-naïve program (Study A4001026), while continuing the other two arms of the study, maraviroc 300mg twice daily versus efavirenz 600mg once daily, unchanged. Both these agents are given in combination with zidovudine/lamivudine in this study.
This pre-specified analysis of Study A4001026 by the DSMB was put in place to ensure patient safety. It provided the DSMB with the opportunity to recommend discontinuation of a maraviroc treatment arm, should either fail to demonstrate non-inferiority to the efavirenz treatment arm. A review of the first 205 subjects treated for 16 weeks showed that maraviroc, given once daily at 300 mg in combination with zidovudine/lamivudine, failed to meet pre-specified non-inferiority criteria versus efavirenz plus zidovudine/lamivudine. The DSMB suggested that patients responding to the once-daily maraviroc combination should be offered the option of switching to twice-daily dosing of maraviroc.
Pfizer is informing all patients, investigators, ethics committees and regulatory authorities of this protocol change.
More than 1400 patients have enrolled in the maraviroc clinical development program to date. For more information about maraviroc clinical trials, please visit www.clinicaltrials.org