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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 September 2022 |
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Main ID: |
NCT03013673 |
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Date of registration:
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05/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Predicting Visceral Leishmaniasis in HIV Infected Patients
PreLeisH |
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Scientific title:
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Predicting Visceral Leishmaniasis in HIV Infected Patients |
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Date of first enrolment:
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October 11, 2017 |
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Target sample size:
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566 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03013673 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Ethiopia
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Contacts
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Name:
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Johan van Griensven, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Tropical Medicine, Antwerp, Belgium |
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Name:
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Ermias Diro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Confirmed HIV-positive
- Enrolled in HIV care at the study site
Exclusion Criteria:
- Age under 18 years
- Diagnosis of active Visceral Leishmaniasis at enrolment
- Unlikely to seek health care again at this site during the next two years
- Not able or willing to provide informed consent. For patients not able to provide
informed consent: No guardian available or willing to provide IC
- Medical emergency, underlying chronic medical condition, or other circumstances that
make adherence to the study unlikely, or participation in the study medically
inadvisable.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Leishmaniasis, Visceral
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Intervention(s)
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Other: No intervention
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Primary Outcome(s)
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Incidence rate of active VL
[Time Frame: January 2020]
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Incidence rate of asymptomatic Leishmania infection
[Time Frame: January 2020]
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Prognostic tool for active VL
[Time Frame: January 2021]
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Evolution of Leishmania infection markers
[Time Frame: January 2020]
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Prevalence of asymptomatic Leishmania infection
[Time Frame: January 2018]
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Risk factors for active VL
[Time Frame: January 2020]
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Secondary Outcome(s)
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Evolution of host immune markers
[Time Frame: January 2020]
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Patterns in host immune markers for asymptomatic Leishmania infection
[Time Frame: January 2020]
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Patterns in host immune markers for VL relapse
[Time Frame: January 2021]
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Patterns in host immune markers for VL treatment failure
[Time Frame: January 2021]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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