Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT00775294
Status:
COMPLETED
Last Update Posted:
2011-05-13
First Post:
2008-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Healthy Males to Measure Maraviroc in Blood, Saliva, Seminal Fluid, and Rectal Tissue
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
A Phase IV, Open Label Study in Healthy Male Subjects to Investigate the Extent of Maraviroc Exposure in Blood, Saliva, Seminal Fluid, and Rectal Mucosal Tissue Following Single and Multiple Dosing of Maraviroc
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to look at how the body handles the drug maraviroc. It will measure the amount of maraviroc in blood, semen, saliva and in the rectum of men. The aim is to understand how much of the drug (taken by mouth) reaches the oral, reproductive and intestinal tracts. It is believed that the presence of this drug in these areas may be beneficial in preventing the AIDS virus (HIV) from being passed from one person to another. The study will take samples of blood, saliva, semen and rectal mucosal tissue to measure drug levels. This study will also collect information on side effects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: