Status:
TERMINATED
CMV Infection in Adolescent Males
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Infections
Eligibility:
MALE
12-17 years
Brief Summary
The purpose of this study is to find out more about cytomegalovirus (CMV) and how it is spread between people. One thousand adolescent males ages 12-17 years will participate in this study. Participan...
Detailed Description
The objectives of this study are to: (1) to determine the prevalence of cytomegalovirus (CMV) infection and risk factors for infection in adolescent males; (2) to prospectively define the incidence an...
Eligibility Criteria
Inclusion
- Subjects must be willing and able to provide written informed assent prior to enrollment, and parent(s) or legal guardian must provide written informed consent prior to study enrollment. 2. Subjects must be male and between 12 to 17 years of age at the time of initial study entry. 3. Subjects must be willing and able to comply with the requirements of the protocol and must be available for the 24-month duration of the study (for Prospective Risk Factor Analysis portion of the study only). 4. Subjects must be willing and able to comply with the requirements of the protocol and must be available for the 12-month duration of the study (for CMV Viral Load Analysis).
Exclusion
- Receipt of blood and/or blood products in the past 3 months (Subjects meeting this exclusion criterion will also be excluded from the Seroprevalence study visit); 2. Unable to comply with the study protocol; 3. Infection with CMV prior to Seroprevalence study (for Prospective Risk Factor Analysis and CMV Viral Load Analysis portions of the study only); 4. History of any physical, mental or developmental disorder that study personnel believe may hinder a participant's ability to comply with study requirements (for Prospective Risk Factor Analysis and CMV Viral Load Analysis portions of the study only); 5. History of malignancy or having a confirmed or suspected immunodeficient condition such as HIV infection or receipt of immunosuppressive drugs. Inhaled and topical corticosteroids will be allowed (for Prospective Risk Factor Analysis and CMV Viral Load Analysis portions of the study only); 6. Receipt of or history of receipt of any medications or treatments that affect the immune system, such as immune globulin, interferon, immunomodulators, cytotoxic drugs, or other drugs known to be frequently associated with significant major organ toxicity or systemic steroids (oral or injectable) in the past 6 months (for Prospective Risk Factor Analysis and CMV Viral Load Analysis portions of the study only); 7. Prior receipt of a CMV vaccine.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT00302029
Start Date
June 1 2006
End Date
December 1 2008
Last Update
November 11 2011
Active Locations (3)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
2
Vanderbilt University
Nashville, Tennessee, United States, 37232-9900
3
The University of Texas Medical Branch
Galveston, Texas, United States, 77555