Maraviroc Shows Promise in Treating HIV/AIDS

Strategic Insights -

A promising new drug, maraviroc, has shown encouraging results in early-stage clinical trials for the treatment of HIV/AIDS. Presented at the 3rd International AIDS Society Conference on Pathogenesis and Treatment, the research indicates that maraviroc is well-tolerated and significantly decreases patient levels of HIV in asymptomatic patients. This investigational drug works through a unique mechanism of action, blocking HIV from entering white blood cells where it replicates and destroys the immune system.

Key Takeaways:

  • Maraviroc, a CCR5-antagonist, blocks HIV from entering white blood cells, reducing viral load by 1.6-1.84 log in 10-day monotherapy studies.
  • Safety data from six phase 1/2a studies involving 259 healthy and HIV-positive volunteers showed maraviroc's safety profile was similar to placebo in doses up to 300 mg twice-daily.
  • The most common adverse events reported were headache, dizziness, nausea, asthenia, and flatulence.
  • Pfizer researchers identified the lead compound for maraviroc in 1997, and it is now in advanced development with worldwide phase 2b/3 trials underway.
  • An independent Data Safety Monitoring Board (DSMB) oversees the studies, and the U.S. FDA has granted fast track designation for maraviroc's clinical development program.
  • Pfizer is committed to bringing meaningful improvement to the lives of people living with HIV/AIDS and those at risk worldwide, with initiatives including the U.S. Southern States HIV/AIDS Prevention Initiative and the building of the Infectious Disease Institute in Kampala, Uganda.

Statistics:

  • Maraviroc reduced HIV viral load by 1.6-1.84 log in 10-day monotherapy studies.
  • Six phase 1/2a studies involving 259 healthy and HIV-positive volunteers showed maraviroc's safety profile was similar to placebo in doses up to 300 mg twice-daily.
  • 63 patients participated in the 10-day monotherapy studies.
  • Pfizer is conducting worldwide phase 2b/3 trials for maraviroc.

Sources:

  • The 3rd International AIDS Society Conference on Pathogenesis and Treatment
  • Pfizer researchers, identified in 1997
  • U.S. Food and Drug Administration (FDA)
  • John LaMattina, PhD, president of Pfizer Global Research and Development
  • World Disease Weekly editors from staff and other reports. Copyright 2005, World Disease Weekly via NewsRx.com.