HSV Oral Reactivation in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01878279
First received: June 11, 2013
Last updated: June 12, 2013
Last verified: June 2013
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HSV copy number [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • compliance with daily swabs [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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