CMV Disease and IRIS in HIV-1 Infected Persons

NCT ID: NCT00456664

Last Updated: 2009-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-07-31

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 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.

Conditions

HIV Infections; Cytomegalovirus

Interventions

IE gene

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of HIV-1 Disease
• Clinical diagnosis of CMV disease or immune restoration inflammatory syndrome (IRIS)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Jih-Jin Tsai, M.D.

Role: STUDY_DIRECTOR

Chung-Ho Memorial Hospital,Kaohsiung Medical University

Locations

Kaoshing Medical University Chung-Ho Memorial Hospital

Kaoshiung, , Taiwan

Countries

Taiwan

Other Identifiers

QM094007

Identifier Type: -

Identifier Source: org_study_id