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Clinical Trials/NCT01878279
NCT01878279
Completed
Not Applicable

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

Dartmouth-Hitchcock Medical Center1 site in 1 country30 target enrollmentSeptember 2008
ConditionsHSV-1HIV

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HSV-1
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
30
Locations
1
Primary Endpoint
HSV detection rate
Status
Completed
Last Updated
12 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
July 2010
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

HSV detection rate

Time Frame: 14 days

Secondary Outcomes

  • HSV copy number(14 days)

Study Sites (1)

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