Predicting Visceral Leishmaniasis in HIV Infected Patients

Terminated

• Conditions: Leishmaniasis, Visceral
• Interventions: Other: No intervention

• Registration Number: NCT03013673
• Lead Sponsor: Institute of Tropical Medicine, Belgium

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Study Start: 2017-10-11
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 566

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV	No intervention	HIV infected individuals residing in VL-endemic areas in Northern Ethiopia

Primary Outcome Measures

Name	Time	Method
Incidence rate of active VL	January 2020	The number of individuals who develop active VL per person-years at risk during follow-up, among all enrolled participants
Prognostic tool for active VL	January 2021	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
Incidence rate of asymptomatic Leishmania infection	January 2020	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
Prevalence of asymptomatic Leishmania infection	January 2018	The proportion of individuals with asymptomatic Leishmania infection at enrolment, among all enrolled participants
Evolution of Leishmania infection markers	January 2020	The proportions of individuals with positive test results for the different Leishmania infection markers at each follow-up visit
Risk factors for active VL	January 2020	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

Secondary Outcome Measures

Name	Time	Method
Patterns in host immune markers for asymptomatic Leishmania infection	January 2020	The association between asymptomatic Leishmania infection and the levels of the different host immune markers, among participants tested for host immune markers
Patterns in host immune markers for VL treatment failure	January 2021	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
Evolution of host immune markers	January 2020	The average levels of the different host immune markers at each follow-up visit
Patterns in host immune markers for VL relapse	January 2021	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

Trial Locations

Locations (1)

Abdurafi Health Center; 🇪🇹 Abderafi, Amhara, Ethiopia