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HSV Oral Reactivation in Children

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01878279
Enrollment
30
Registered
2013-06-14
Start date
2008-09-30
Completion date
Unknown
Last updated
2013-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, HSV-1

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

Interventions

OTHERUnderlying medical illness

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
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

Design outcomes

Primary

MeasureTime frame
HSV detection rate14 days

Secondary

MeasureTime frame
HSV copy number14 days

Other

MeasureTime frame
compliance with daily swabs14 days

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026