NCT03013673|Terminated
Study Stopped
Due to the ongoing conflict in the Tigray region
Predicting Visceral Leishmaniasis in HIV Infected Patients
PreLeisH
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Sponsor study identifier
observational
566
1 country
1
Study Start
October 11, 2017
Actual (reported)Primary Completion
May 31, 2021
Actual (reported)Study Completion
May 31, 2021
Actual (reported)In this cohort study, the investigators will study the asymptomatic period preceding the onset of active Visceral Leishmaniasis (VL) in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 5, 2017
Actual (reported)January 6, 2017
Actual (reported)October 11, 2017
Actual (reported)May 31, 2021
Actual (reported)May 31, 2021
Actual (reported)Prevalence of asymptomatic Leishmania infection
The proportion of individuals with asymptomatic Leishmania infection at enrolment, among all enrolled participants
January 2018
Incidence rate of asymptomatic Leishmania infection
The number of individuals with newly diagnosed asymptomatic Leishmania infection per person-years at risk during follow-up, among participants without Leishmania infection at enrolment
January 2020
Evolution of Leishmania infection markers
The proportions of individuals with positive test results for the different Leishmania infection markers at each follow-up visit
January 2020
Incidence rate of active VL
The number of individuals who develop active VL per person-years at risk during follow-up, among all enrolled participants
January 2020
Risk factors for active VL
The association between the risk to develop active VL during follow-up and demographic/clinical characteristics as well as HIV/host immunity/Leishmania infection markers from baseline onwards
Patterns in host immune markers for asymptomatic Leishmania infection
January 2020
Evolution of host immune markers
January 2020
Patterns in host immune markers for VL treatment failure
January 2021
Patterns in host immune markers for VL relapse
January 2021
HIV infected individuals residing in VL-endemic areas in Northern Ethiopia
No intervention
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
HIV-infected individuals residing in VL-endemic areas in Northern Ethiopia
Abdurafi Health Center
Ābderafī, Amhara, Ethiopia
Diro E, Ritmeijer K, van Henten S, Kibret A, Kassa M, Beyene H, Adriaensen W, Pareyn M, van Griensven J. A Diagnostic Algorithm Based on Urine Antigen and Blood Polymerase Chain Reaction Testing for Visceral Leishmaniasis in HIV-Coinfected Patients in Northwest Ethiopia. Am J Trop Med Hyg. 2026 Sep 15:tpmd260104. doi: 10.4269/ajtmh.26-0104. Online ahead of print.
All samples and sample left-overs (blood and urine) not used during the course of this study will be stored for 25 years after the end of the study.
Johan van Griensven, MD PhD
Institute of Tropical Medicine, Antwerp, Belgium
Ermias Diro, MD
College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
566 participants (actual enrollment reported by the registry).
First Submitted
January 5, 2017
First Posted
January 6, 2017
Study Start
October 11, 2017
Actual (reported)Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.
January 2020
Prognostic tool for active VL
A clinical decision algorithm, prioritizing and integrating identified risk factors, that is able to most efficiently predict the risk of developing active VL within 12 months
January 2021
Contact the study team to confirm eligibility.
Primary Completion
May 31, 2021
Actual (reported)Study Completion
May 31, 2021
Actual (reported)Last Updated
September 9, 2022
Record last verified: 2022-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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