HSV Oral Reactivation in Children

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01878279
• Collaborator: (none)
• Enrollment: 30
• Location: 1

Study Details

Study Description

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

Secondary Objectives:

1. To determine the acceptability of performing daily oral swabs in children age 3-12

Condition or Disease	Intervention/Treatment	Phase
HSV-1; HIV	Other: Underlying medical illness

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Longitudinal Study to Evaluate the Frequency of HSV-1 Oral Reactivation in Children in Dar es Salaam, Tanzania
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
HIV negative
HIV positive HIV positive children in care	Other: Underlying medical illness

Outcome Measures

Primary Outcome Measures

1. HSV detection rate [14 days]

Secondary Outcome Measures

1. HSV copy number [14 days]

Other Outcome Measures

1. compliance with daily swabs [14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MUHAS	Dar es Salaam		Tanzania

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center

Investigators

• Principal Investigator: Richard Zuckerman, MD, MPH, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Epub 2005 Nov 21.
• Kasubi MJ, Nilsen A, Marsden HS, Bergström 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.

• Responsible Party: Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT01878279
• Other Study ID Numbers: 21397
• First Posted: Jun 14, 2013
• Last Update Posted: Jun 14, 2013
• Last Verified: Jun 1, 2013

Study Results

No Results Posted as of Jun 14, 2013