HSV Oral Reactivation in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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HSV-1 HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV negative

No interventions assigned to this group

HIV positive

HIV positive children in care

Underlying medical illness

Intervention Type OTHER

Interventions

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Underlying medical illness

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes