Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-01-03 @ 7:23 PM
Study NCT ID:
NCT00665561
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2008-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Observational Epidemiologic Study of Maraviroc's Safety
Sponsor:
ViiV Healthcare
Organization:
Study Overview
Official Title:
AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS
Status:
COMPLETED
Status Verified Date:
2022-10
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:
POEM
Brief Summary:
The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.
Detailed Description:
All patients meeting the study eligibility criteria at participating sites will be invited to participate.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: