NCT00426660

Expanded Access Program for Maraviroc At Multiple Centers

A Multicenter, Open Label, Expanded Access Trial Of Maraviroc

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,047 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	maraviroc	The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2007-01-25
• Last updated: 2016-06-29
• Results posted: 2011-10-17

Locations

361 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Malaysia, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Spain, Switzerland, Taiwan, United Kingdom