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CMV Disease and IRIS in HIV-1 Infected Persons

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00456664
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : February 3, 2009
Sponsor:
Information provided by:

April 4, 2007
April 5, 2007
February 3, 2009
November 2006
July 2008   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00456664 on ClinicalTrials.gov Archive Site
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CMV Disease and IRIS in HIV-1 Infected Persons
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
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.

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.

Observational
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  • HIV Infections
  • Cytomegalovirus
Genetic: IE gene
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of HIV-1 Disease
  • Clinical diagnosis of CMV disease or immune restoration inflammatory syndrome (IRIS)
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00456664
QM094007
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Kaohsiung Medical University Chung-Ho Memorial Hospital
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Study Director: Jih-Jin Tsai, M.D. Chung-Ho Memorial Hospital,Kaohsiung Medical University
Kaohsiung Medical University Chung-Ho Memorial Hospital
May 2008