HSV Oral Reactivation in Children

HIV Clinical Trial

Official title:

Longitudinal Study to Evaluate the Frequency of HSV-1 Oral Reactivation in Children in Dar es Salaam, Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878279
• Other study ID #: 21397
• Status: Completed
• Phase: N/A
• First received: June 11, 2013
• Last updated: June 12, 2013
• Start date: September 2008

Study information

• Verified date: June 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV
• HSV-1

Intervention

Other:
• Underlying medical illness

Locations

Country	Name	City	State
Tanzania	MUHAS	Dar es Salaam

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

Tanzania, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	compliance with daily swabs		14 days	No
Primary	HSV detection rate		14 days	No
Secondary	HSV copy number		14 days	No