CMV Disease and IRIS in HIV-1 Infected Persons
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections Cytomegalovirus |
Genetic: IE gene |
| Study Type: | Observational |
| 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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Clinical diagnosis of HIV-1 Disease
- Clinical diagnosis of CMV disease or immune restoration inflammatory syndrome (IRIS)
Contacts and Locations| Taiwan | |
| Kaoshing Medical University Chung-Ho Memorial Hospital | |
| Kaoshiung, Taiwan | |
| Study Director: | Jih-Jin Tsai, M.D. | Chung-Ho Memorial Hospital,Kaohsiung Medical University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00456664 History of Changes |
| Other Study ID Numbers: | QM094007 |
| Study First Received: | April 4, 2007 |
| Last Updated: | February 1, 2009 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
|
CMV IRIS |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 21, 2013