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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01878279
Other study ID # 21397
Secondary ID
Status Completed
Phase N/A
First received June 11, 2013
Last updated June 12, 2013
Start date September 2008

Study information

Verified date June 2013
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 12 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Underlying medical illness


Locations

Country Name City State
Tanzania MUHAS Dar es Salaam

Sponsors (1)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

Tanzania, 

References & Publications (2)

Grando LJ, Machado DC, Spitzer S, Nachman S, Ferguson F, Berentsen B, Yurgel LS. Viral coinfection in the oral cavity of HIV-infected children: relation among HIV viral load, CD4+ T lymphocyte count and detection of EBV, CMV and HSV. Braz Oral Res. 2005 Jul-Sep;19(3):228-34. Epub 2005 Nov 21. — View Citation

Kasubi MJ, Nilsen A, Marsden HS, Bergström T, Langeland N, Haarr L. Prevalence of antibodies against herpes simplex virus types 1 and 2 in children and young people in an urban region in Tanzania. J Clin Microbiol. 2006 Aug;44(8):2801-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other compliance with daily swabs 14 days No
Primary HSV detection rate 14 days No
Secondary HSV copy number 14 days No
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