Cytomegalovirus Spread and Reactivation in Blood Cells - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 28, 2000

Last Updated Date

January 27, 2006

Start Date ^†

July 1999

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00006314 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Cytomegalovirus Spread and Reactivation in Blood Cells

Official Title ^†

Brief Summary

To investigate the relationship between HCMV and bone marrow progenitor cells to understand whether HCMV is latent in CD34 + bone marrow progenitors and the mechanism by which the virus remains in a latent state.

Detailed Description

BACKGROUND:

Despite progress in understanding the pathophysiology of human cytomegalovirus (HCMV) infections, its manifestations in the immune compromised host are frequently associated with high morbidity and mortality. In this setting, HCMV disease can develop e.g. following immune suppression as a result of reactivation of latent HCMV acquired earlier in life. The mechanisms leading to establishment of latent infections and their subsequent reactivation are not clear. It is also unknown whether HCMV exists in a latent form with limited viral gene expression or as a persistent infection with normal virus transcription.

DESIGN NARRATIVE:

The specific aims of the study were to: 1) examine the percentage of HCMV positive donors whose bone marrow progenitors contained HCMV DNA using nested PCR and determine if virus could be rescued from those cells. 2) Analyze the HCMV life cycle in hematopoietic progenitor and stem cells. 3) identify and analyze HCMV gene expression in in vivo infected leukocytes. Bone marrow progenitors containing HCMV DNA detectable by nested PCR were isolated from human donors and used as as source of mRNA to prepare Cdna libraries. 4) Determine if gene(s) expressed in bone marrow progenitors were important in either establishing or maintaining a latent infection or in the lytic cycle of HCMV. Information provided from the above studies yielded information important in planning future approaches for the therapy of HCMV infections.

Study Phase

Study Type ^†

Observational

Study Design ^†

Natural History

Condition ^†

Blood Disease
Cytomegalovirus Infections

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

June 2004

Primary Completion Date

Eligibility Criteria ^†

No eligibility criteria

Gender

Male

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00006314

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^††

Investigators ^†

Investigator:

Stephen St. Jeor

University of Nevada

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

January 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.