Predicting Visceral Leishmaniasis in HIV Infected Patients

Leishmaniasis, Visceral Clinical Trial

— PreLeisH  

Official title:

Predicting Visceral Leishmaniasis in HIV Infected Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03013673
• Other study ID #: ITM0915
• Status: Terminated
• Start date: October 11, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2022
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

HIV co-infection drastically increases the risk of developing active VL. Clinical outcomes are dire in immune-compromised patients even with the best available treatment, and relapse is frequent. The incubation period may provide an important window of opportunity for a pre-emptive "screen an treat" approach in HIV co-infected patients to prevent progression from infection to the active disease. However, no recommendations exist to date due to lack of solid evidence. It is not known which patients are at highest risk of disease progression, which role parasite/host/HIV factors play in the asymptomatic infection phase, and what the diagnostic values of existing Leishmania infection markers are. Such information is needed to develop a prognostic clinical tool for the detection of HIV patients at high risk of developing active VL. Therefore, the aim is to study the asymptomatic period preceding the onset of active 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. This will be a prospective cohort study with one year of follow-up for patients who remain VL free. Patients developing active VL during the study period will be followed until the end of the study duration.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 566
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Visceral

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Ethiopia	Abdurafi Health Center	Abderafi	Amhara

Sponsors (4)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Bureau of Health, Abdurafi, Ethiopia, Medecins Sans Frontieres, Netherlands, University of Gondar, Gondar, Ethiopia

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of asymptomatic Leishmania infection	The proportion of individuals with asymptomatic Leishmania infection at enrolment, among all enrolled participants	January 2018
Primary	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
Primary	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
Primary	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
Primary	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	January 2020
Primary	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
Secondary	Patterns in host immune markers for asymptomatic Leishmania infection	The association between asymptomatic Leishmania infection and the levels of the different host immune markers, among participants tested for host immune markers	January 2020
Secondary	Evolution of host immune markers	The average levels of the different host immune markers at each follow-up visit	January 2020
Secondary	Patterns in host immune markers for VL treatment failure	The association between the risk of VL treatment failure and the levels and evolution of the different host immune markers, among participants who develop active VL and receive VL treatment	January 2021
Secondary	Patterns in host immune markers for VL relapse	The association between the risk of VL relapse and the levels and evolution of the different host immune markers, among participants who develop active VL	January 2021