Observational Study on New and Recurrent Visceral Leishmaniasis in Adults with HIV in Ethiopia

What this Trial Is About

Researchers are investigating the causes and factors that lead to relapse and parasite persistence in patients with visceral leishmaniasis VL who also have HIV infection in Ethiopia. The study aims to better understand how these infections interact, particularly focusing on why some patients experience chronic or recurrent disease despite treatment. This observational cohort study includes both new and retrospective patient data to analyze clinical, laboratory, and molecular findings. Participants will be observed over time without receiving experimental treatments. The study will monitor parasite levels in blood and tissue samples before, during, and after treatment, and during follow-up. Researchers will also examine HIV co-infection characteristics, potential drug resistance, parasite genetics, and other latent infections like tuberculosis and malaria. Quality of life assessments and exploratory studies on skin parasite persistence and stool microbiome will also be conducted. Participants will undergo routine clinical and laboratory evaluations, molecular diagnostic tests, and standardized questionnaires to assess quality of life. The main outcome is identifying host and pathogen factors linked to active chronic infection over 12 months. Participants are expected to attend follow-up visits to support monitoring and data collection. The study will run until December 2027 and does not involve interventional treatments.

Recurrent Visceral Leishmaniasis in HIV Co-Infection