Ignite Creation Date:
2025-12-17 @ 3:22 PM
Ignite Modification Date:
2025-12-23 @ 10:31 PM
Study NCT ID:
NCT00745368
Status:
COMPLETED
Last Update Posted:
2012-10-10
First Post:
2008-09-01
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women
Status:
COMPLETED
Status Verified Date:
2012-09
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:
The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
Detailed Description:
Although we have many medications to fight the HIV virus, very little is known about how much of these medications get into the genital tract. Raltegravir is a new HIV medication that blocks HIV growth and lowers the amount of virus in the blood in a way that is different than all other currently available HIV medications. Raltegravir was recently approved by the Food and Drug Administration (FDA) for use in HIV infected patients, but there is very little information concerning how much raltegravir will reach the genital tract of men or women. The purpose of this research study is to determine how much raltegravir gets into the male and female genital tract.
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?: