NCT00456664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

February 3, 2009

Status Verified

May 1, 2008

Enrollment Period

1.7 years

First QC Date

April 4, 2007

Last Update Submit

February 1, 2009

Conditions

HIV InfectionsCytomegalovirus

Keywords

CMVIRIS

Interventions

IE geneGENETIC

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaoshing Medical University Chung-Ho Memorial Hospital

Kaoshiung, Taiwan

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Jih-Jin Tsai, M.D.

    Chung-Ho Memorial Hospital,Kaohsiung Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

November 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 3, 2009

Record last verified: 2008-05

Locations

TW(1)