Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00456664
Status:
COMPLETED
Last Update Posted:
2009-02-03
First Post:
2007-04-04
Brief Title:
CMV Disease and IRIS in HIV-1 Infected Persons
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Overview
Official Title:
Molecular Diagnostics for CMV Disease and IRIS in HIV-1 Infected Persons and the Mechanism Study for CMV Alternative Gene Splicing in Immediate Early Protein
Status:
COMPLETED
Status Verified Date:
2008-05
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:
Various diagnostic methods are available for CMV infection But none of them could be a standard and highly valuable Our first goal is to setup a series of molecular diagnostic tools for HIV-1 infected person By using these tools physicians can easily select cases with CMV disease or immune restoration inflammatory syndrome IRIS to enroll this study Furthermore we will seek for a predict marker for CMV reactivation CMV disease and IRIS Finally our research will focus on the mechanism of the IE gene alternative splicing between lytic and latent stage
Detailed Description:
At present human cytomegalovirus HCMV remains a major health threat in immune compromised patients Especially HCMV will cause blind and death in HIV-1 infected person Currently few antiviral drugs can be chosen for treatment of HCMV infection Besides more and more drug resistant virus strains were reported and led failure in antiviral therapy
Various diagnostic methods are available for CMV infection Such as shell vial assay CMV antigen test pp65 antigen assay and polymerase chain reaction But none of them could be a standard and highly valuable Although CMV-PCR is very sensitive it cant distinguish between active disease and asymptomatic infection or latency cant predict symptomatic disease nor cant monitor the successful antiviral therapy
Our first goal is to setup a series of molecular diagnostic tools for HIV-1 infected person By using these tools physicians can easily select cases with CMV disease or immune restoration inflammatory syndrome IRIS to enroll this study Furthermore we will seek for a predict marker for CMV reactivation CMV disease and IRIS Finally our research will focus on the mechanism of the IE gene alternative splicing between lytic and latent stage We may find out new therapeutic concept and prevent virus reactivation from latency
Various diagnostic methods are available for CMV infection Such as shell vial assay CMV antigen test pp65 antigen assay and polymerase chain reaction But none of them could be a standard and highly valuable Although CMV-PCR is very sensitive it cant distinguish between active disease and asymptomatic infection or latency cant predict symptomatic disease nor cant monitor the successful antiviral therapy
Our first goal is to setup a series of molecular diagnostic tools for HIV-1 infected person By using these tools physicians can easily select cases with CMV disease or immune restoration inflammatory syndrome IRIS to enroll this study Furthermore we will seek for a predict marker for CMV reactivation CMV disease and IRIS Finally our research will focus on the mechanism of the IE gene alternative splicing between lytic and latent stage We may find out new therapeutic concept and prevent virus reactivation from latency
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