CMV Disease and IRIS in HIV-1 Infected Persons
|ClinicalTrials.gov Identifier: NCT00456664|
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : February 3, 2009
|Condition or disease||Intervention/treatment|
|HIV Infections Cytomegalovirus||Genetic: IE gene|
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 can't distinguish between active disease and asymptomatic infection or latency, can't predict symptomatic disease nor can't 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 Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456664
|Kaoshing Medical University Chung-Ho Memorial Hospital|
|Study Director:||Jih-Jin Tsai, M.D.||Chung-Ho Memorial Hospital,Kaohsiung Medical University|