Maraviroc Compassionate Use
The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Maraviroc Compassionate Use|
- Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two Years ] [ Designated as safety issue: Yes ]
- Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Maraviroc 150mg, 300 mg or 600 mg twice daily administered orally with or without food in combination with other antiretroviral agents. The recommended dose of Maraviroc differs based on concomitant medications due to drug interactions as outlined in the Prescribing Information.
This study was cancelled prior to enrollment.