HSV Oral Reactivation in Children

Dartmouth Health

Status: Completed

Conditions: HIV; HSV-1

Treatments: Other: Underlying medical illness

Study type: Observational

Funder types: Other

Identifiers

NCT01878279

21397

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

HIV negative

HIV positive

Description:

HIV positive children in care

Treatment:

Other: Underlying medical illness