HSV Oral Reactivation in Children
Longitudinal Study to Evaluate the Frequency of HSV-1 Oral Reactivation in Children in Dar es Salaam, Tanzania
1 other identifier
observational
30
1 country
1
Brief Summary
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:
- 1.To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected children
- 2.To determine the acceptability of performing daily oral swabs in children age 3-12
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 14, 2013
CompletedJune 14, 2013
June 1, 2013
1.8 years
June 11, 2013
June 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
HSV detection rate
14 days
Secondary Outcomes (1)
HSV copy number
14 days
Other Outcomes (1)
compliance with daily swabs
14 days
Study Arms (2)
HIV negative
HIV positive
HIV positive children in care
Interventions
Eligibility Criteria
For this Pilot study, we will enroll 20 HIV-infected and 10 HIV-uninfected children
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MUHAS
Dar es Salaam, Tanzania
Related Publications (2)
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.
PMID: 16891495BACKGROUNDGrando 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.
PMID: 16308613BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Zuckerman, MD, MPH
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2013
First Posted
June 14, 2013
Study Start
September 1, 2008
Primary Completion
July 1, 2010
Last Updated
June 14, 2013
Record last verified: 2013-06