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DSMB Recommends maraviroc (Pfizer CCR5 drug) phase 2b/3 studies continue as designed  
 
 
  October 14, 2005
 
Pfizer today said that the independent Data Safety Monitoring Board (DSMB) for maraviroc, a CCR5 antagonist in development for the treatment of HIV, met in July and again in September of 2005 and recommended that all Phase 2b/3 clinical studies in antiretroviral-naive and antiretroviral-experienced patients for the investigational medicine continue as currently designed.
 
The DSMB delivered these assessments after comprehensive reviews of maraviroc efficacy, safety, and laboratory data (including hepatic enzyme abnormalities). In July they reviewed data from all studies in antiretroviral-naive and antiretroviral-experienced patients and in September reviewed data from the study in antiretroviral-naive patients and one of the studies in treatment-experienced patients. Maraviroc clinical trials have been ongoing since November 2004 and have enrolled more than 1000 patients to date. A proportion of patients have exceeded 24 weeks of therapy.
 
The maraviroc DSMB is an independent group that includes experts who specialize in the treatment of patients with HIV/AIDS.
 
CCR5-antagonists block HIV from entering white blood cells, where the virus replicates. In the absence of entry inhibitors, HIV can enter white blood cells, take over the cellfs DNA for its own reproduction, and ultimately destroy a patientfs immune system.
 
For more information about maraviroc clinical trials please visit www.clinicaltrials.gov.
 
 
 
 
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