NCT03013673

Predicting Visceral Leishmaniasis in HIV Infected Patients

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 566 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leishmaniasis, Visceral

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2017-10-11
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2017-01-06
• Last updated: 2022-09-09

Locations

1 site across 1 country: Ethiopia