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CMV Disease and IRIS in HIV-1 Infected Persons

Primary Purpose

HIV Infections, Cytomegalovirus

Status
Completed
Phase
Locations
Taiwan
Study Type
Observational
Intervention
IE gene
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring CMV, IRIS

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • Kaoshing Medical University Chung-Ho Memorial Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 4, 2007
Last Updated
February 1, 2009
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00456664
Brief Title
CMV Disease and IRIS in HIV-1 Infected Persons
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 Type
Observational

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Cytomegalovirus
Keywords
CMV, IRIS

7. Study Design

Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
IE gene

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of HIV-1 Disease Clinical diagnosis of CMV disease or immune restoration inflammatory syndrome (IRIS)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jih-Jin Tsai, M.D.
Organizational Affiliation
Chung-Ho Memorial Hospital,Kaohsiung Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Kaoshing Medical University Chung-Ho Memorial Hospital
City
Kaoshiung
Country
Taiwan

12. IPD Sharing Statement

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CMV Disease and IRIS in HIV-1 Infected Persons

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