- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01878279
HSV Oral Reactivation in Children
June 12, 2013 updated by: Dartmouth-Hitchcock Medical Center
Longitudinal Study to Evaluate the Frequency of HSV-1 Oral Reactivation in Children in Dar es Salaam, Tanzania
In the proposed study, the investigators will carry out novel research to evaluate both symptomatic and asymptomatic daily oral herpes simplex virus (HSV) shedding rates and copy number in children with and without HIV.
Study Objectives:
To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected children
Secondary Objectives:
- To determine the acceptability of performing daily oral swabs in children age 3-12
Study Overview
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dar es Salaam, Tanzania
- MUHAS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
For this Pilot study, we will enroll 20 HIV-infected and 10 HIV-uninfected children
Description
Inclusion Criteria:
- age > 3 and ≤12 years old
- parental/guardian consent and children's assent must be obtained and participants and parent/guardian must be able to comply with study procedures
- For HIV-infected group: Positive HIV serology by either ELISA x 2, ELISA + WB or PCR testing
Exclusion Criteria:
- age <3 and > 12 years old
- Acute illness which by opinion of the investigator makes enrollment in the trial unfeasible (including active tuberculosis, malaria or other opportunistic infection requiring treatment)
- co-enrollment in other therapeutic/intervention trials (observational trial enrollment is permitted).
- Stable co-administration of other medications is permitted (e.g. bactrim)
- For HIV-infected children; receiving or eligible for antiretroviral (ART) therapy by local standards
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HIV negative
|
|
HIV positive
HIV positive children in care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HSV detection rate
Time Frame: 14 days
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HSV copy number
Time Frame: 14 days
|
14 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
compliance with daily swabs
Time Frame: 14 days
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard Zuckerman, MD, MPH, Dartmouth-Hitchcock Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kasubi MJ, Nilsen A, Marsden HS, Bergstrom T, Langeland N, Haarr L. Prevalence of antibodies against herpes simplex virus types 1 and 2 in children and young people in an urban region in Tanzania. J Clin Microbiol. 2006 Aug;44(8):2801-7. doi: 10.1128/JCM.00180-06.
- Grando LJ, Machado DC, Spitzer S, Nachman S, Ferguson F, Berentsen B, Yurgel LS. Viral coinfection in the oral cavity of HIV-infected children: relation among HIV viral load, CD4+ T lymphocyte count and detection of EBV, CMV and HSV. Braz Oral Res. 2005 Jul-Sep;19(3):228-34. doi: 10.1590/s1806-83242005000300013. Epub 2005 Nov 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
July 1, 2010
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
June 11, 2013
First Submitted That Met QC Criteria
June 12, 2013
First Posted (Estimate)
June 14, 2013
Study Record Updates
Last Update Posted (Estimate)
June 14, 2013
Last Update Submitted That Met QC Criteria
June 12, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 21397
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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