NCT07487350

Recurrent Visceral Leishmaniasis in HIV Co-Infection

New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim is (1) to better understand the underlying causes and predispositions for relapse and parasite persistence in visceral leishmaniasis (VL) patients living with HIV and (2) to improve treatment monitoring of this target group in Ethiopia

Detailed description

Prospective and retrospective observational cohort study Main objective \- To identify the key host and pathogen factors that contribute to active chronicity (=recurrent or chronic parasite presence in blood, tissue and/or skin in combination with clinical symptoms) in VL/HIV patients in northern Ethiopia Specific objectives * To describe the VL/HIV patients by level of chronicity using routine clinical and laboratory data * To monitor parasite presence by molecular diagnostic in peripheral blood and - if available - tissue aspirates before, during, after treatment as well as during follow-up by level of disease chronicity * To broadly characterize the underlying HIV co-infection and potential of ART resistance by level of disease chronicity * To genotype the Leishmania parasites by level of disease chronicity to assess re-infection, recrudescence, drug resistance, and quiescence/virulence * To identify other concomitant (latent) co-infections (TB, malaria, intestinal helminths, viral infections) and its impact on disease chronicity * To study the level of exhaustion and immune checkpoint inhibition pathways, as potential therapy targets, by disease chronicity * To assess the quality of life by a standardised questionnaire at admission and during follow-up Exploratory objective: * To study the persistence and quantity of parasites within the skin * To study the stool microbiome of VL-HIV patients * To assess the potential impact of secondary prophylaxis on relapse frequency, relapse intervals, relapse intensity, and exhaustion marker (compared with historical cohort/patients without secondary prophylaxis)

Conditions

• Hiv
• Visceral Leishmaniasis

Timeline

• Start date: 2025-10-21
• Primary completion: 2027-04-01
• Completion: 2027-12-01
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: Ethiopia