HSV Oral Reactivation in Children

Completed

• Conditions: HSV-1; HIV
• Interventions: Other: Underlying medical illness

• Registration Number: NCT01878279
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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:

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2010-07
• Status Verified: 2013-06
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-12
• Last Update Submitted: 2013-06-12
• Study First Posted: 2013-06-14
• Last Update Posted: 2013-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV positive	Underlying medical illness	HIV positive children in care

Primary Outcome Measures

Name	Time	Method
HSV detection rate	14 days

Secondary Outcome Measures

Name	Time	Method
HSV copy number	14 days

Trial Locations

Locations (1)

MUHAS; 🇹🇿 Dar es Salaam, Tanzania