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

June 11, 2013
June 12, 2013
September 2008
July 2010   (final data collection date for primary outcome measure)
HSV detection rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01878279 on ClinicalTrials.gov Archive Site
HSV copy number [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
compliance with daily swabs [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
 
HSV Oral Reactivation in Children
Longitudinal Study to Evaluate the Frequency of HSV-1 Oral Reactivation in Children in Dar es Salaam, Tanzania

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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

For this Pilot study, we will enroll 20 HIV-infected and 10 HIV-uninfected children

  • HSV-1
  • HIV
Other: Underlying medical illness
  • HIV negative
  • HIV positive
    HIV positive children in care
    Intervention: Other: Underlying medical illness

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
July 2010   (final data collection date for primary outcome measure)

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
Both
3 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT01878279
21397
No
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Not Provided
Principal Investigator: Richard Zuckerman, MD, MPH Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP