Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361101
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2006-08-03
Brief Title:
A Study of AMD11070 in HIV-infected Patients Carrying X4-tropic Virus
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Multicenter Dose-finding Safety and Activity Study of AMD11070 in HIV-infected Patients Carrying X4-tropic Virus
Status:
COMPLETED
Status Verified Date:
2014-02
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 study is to determine the safety and activity of AMD11070 in HIV-infected patients carrying X4-tropic virus
Detailed Description:
AMD11070 is a new chemical entity that inhibits HIV-1 entry by binding specifically and reversibly to CXCR4 a coreceptor required by T-tropic virus for membrane fusion and entry into cells The purpose of this study is to evaluate the safety and relative antiretroviral activity of AMD11070 in HIV-infected individuals who have demonstrated X4 -tropic virus in their plasma With the ongoing development of other fusion and entry inhibitors and the need for alternative treatment options in patients especially those with multidrug resistant virus the demonstration of activity and safety of AMD11070 represents a potentially important advance in antiretroviral therapeutics This will be the first study that determines the therapeutic potential of anti-CXCR4 compounds in HIV-infected patients
Note Study was previously suspended due to non-clinical reports of hepatotoxicity and histologic findings Study has been completed
Note Study was previously suspended due to non-clinical reports of hepatotoxicity and histologic findings Study has been completed
Study Oversight
Has Oversight DMC:
None
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?:
None