HSV-1NCT01878279
HSV Oral Reactivation in Children
An observational study of HSV-1 and HIV, run by Dartmouth-Hitchcock Medical Center at 1 site in Tanzania.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Underlying medical illness
- How many people
- 30 participants
- Where
- 1 siteTanzania
- Study dates
- Sep 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: For this Pilot study, we will enroll 20 HIV-infected and 10 HIV-uninfected children
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected children Secondary Objectives:
- To determine the acceptability of performing daily oral swabs in children age 3-12
- Being tested
- Underlying medical illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underlying medical illnessOther
| Study group | Role | What they receive |
|---|---|---|
| HIV negative | Not described | |
| HIV positive | HIV positive children in care Receives: Other: Underlying medical illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
HSV detection rate
Measured: 14 days
Secondary outcomes (1)
HSV copy number
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startSep 2008
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HSV-1Studies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Zuckerman, MD, MPH, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878279
- Sponsor's protocol ID
- 21397
- Status last verified
- Jun 2013
- First submitted
- 11 Jun 2013
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kasubi MJ, Nilsen A, Marsden HS, Bergstrom 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. doi: 10.1128/JCM.00180-06.
PubMed 16891495Grando 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. doi: 10.1590/s1806-83242005000300013. Epub 2005 Nov 21.
PubMed 16308613
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study to Evaluate the Frequency of HSV-1 Oral Reactivation in Children in Dar es Salaam, Tanzania
- ClinicalTrials.gov ID
- NCT01878279
- Acronym / sponsor ID
- 21397
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2010 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected children Secondary Objectives:
- To determine the acceptability of performing daily oral swabs in children age 3-12
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV negative | – | – |
| HIV positive | – | Other: Underlying medical illnessHIV positive children in care |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- For this Pilot study, we will enroll 20 HIV-infected and 10 HIV-uninfected children
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Underlying medical illness | Other | HIV positive |
Primary outcome
HSV detection rate
Time frame: 14 days
1 secondary outcome
HSV copy number
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
- Background: PubMed 16891495Kasubi MJ, Nilsen A, Marsden HS, Bergstrom 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. doi: 10.1128/JCM.00180-06.
- Background: PubMed 16308613Grando 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. doi: 10.1590/s1806-83242005000300013. Epub 2005 Nov 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Zuckerman, MD, MPH principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HSV-1 and HIV, run by Dartmouth-Hitchcock Medical Center at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HSV detection rate (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01878279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2013.