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OpenTrials
Completed

NCT Number: NCT01878279

HSV Oral Reactivation in Children

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

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Key information

Conditions

HSV-1 HIV

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MUHAS

Dar es Salaam, Tanzania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Underlying medical illness

Other

Primary outcomes

  1. HSV detection rate

    Time frame: 14 days

Secondary outcomes

  1. HSV copy number

    Time frame: 14 days

Other outcomes

  1. compliance with daily swabs

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
First posted
Jun 14, 2013
Registry last updated
Jun 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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