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HSV Oral Reactivation in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01878279
First Posted: June 14, 2013
Last Update Posted: June 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose

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

Condition Intervention
HSV-1 HIV Other: Underlying medical illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study to Evaluate the Frequency of HSV-1 Oral Reactivation in Children in Dar es Salaam, Tanzania

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • HSV detection rate [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • HSV copy number [ Time Frame: 14 days ]

Other Outcome Measures:
  • compliance with daily swabs [ Time Frame: 14 days ]

Enrollment: 30
Study Start Date: September 2008
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV negative
HIV positive
HIV positive children in care
Other: Underlying medical illness

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
For this Pilot study, we will enroll 20 HIV-infected and 10 HIV-uninfected children
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878279


Locations
Tanzania
MUHAS
Dar es Salaam, Tanzania
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Richard Zuckerman, MD, MPH Dartmouth-Hitchcock Medical Center
  More Information
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