------------------- GENERAL INFORMATION ------------------- 1. Title of dataset Clinical significance of asymptomatic Leishmania infantum infection in people living with HIV_data set 2. Contact Principal Investigator Contact Information Name:Eugenia Carrillo Institution:Instituto de Salud Carlos III Email: ecarrillo@isciii.es ORCID: 0000-0002-7869-7915 3. Description of the project Among 204 people living with HIV receiving effective antiretroviral therapy in Leishmania infantum-endemic areas of Spain and Italy, asymptomatic Leishmania infection was detected in 26.5% of participants. The whole blood stimulation assay was the most sensitive individual test, while its combination with ELISA showed the highest diagnostic sensitivity. Despite the relatively high prevalence of asymptomatic infection, no participants progressed to visceral leishmaniasis during a median follow-up of 5.8 years. These findings suggest that, in virologically controlled PLWH on continuous ART, asymptomatic L. infantum infection has limited prognostic significance and supports clinical monitoring rather than routine screening or pre-emptive treatment. 4. Description of the dataset This dataset contains demographic, clinical, immunological and molecular data from 204 people living with HIV (PLWH) recruited between 2013 and 2023 in Spain and Italy, all residing in Leishmania infantum-endemic areas. For each participant, the database includes age, sex, birthplace, cohort, CD4+ T-cell count, HIV viral load, antiretroviral treatment information, and the results of three complementary screening methods for asymptomatic Leishmania infection: kDNA real-time PCR, ELISA serology, and a whole blood stimulation assay (WBA) measuring parasite-specific cytokine responses (IFN-γ, IL-2 and IP-10). In addition, the dataset contains follow-up information for individuals with positive screening results, including repeated PCR, serological and immunological assessments and clinical monitoring for progression to visceral leishmaniasis. No cases of progression to overt VL were recorded during follow-up. 5. Notes 6. Deposit date 10/09/2026 7. Date 10/09/2026 8. Language English -------------------------- AUTHOR INFORMATION -------------------------- 1. Author Name: Anna Last name: Barbiero Institution: Department of Clinical and Experimental Medicine, Università degli Studi di Firenze, Firenze, Italy Email: ORCID: 0009-0004-4152-9346 2. Author Name: Javier Last name: Moreno Institution: WHO Collaborating Centre for Leishmaniasis, Spanish National Center for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain Email: javier.moreno@isciii.es ORCID: 0000-0003-0087-4659 3. Author Name: Lorena Last name: Bernardo Institution: Center for Biological Research (CIB), Spanish National Research Council (CSIC), Madrid, Spain Email: lorena.bernardo@cib.csic.es ORCID: 0000-0002-6899-4844 4. Author Name: Marina Last name: Lozano-Rendal Institution: WHO Collaborating Centre for Leishmaniasis, Spanish National Center for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain Email: marina.lozano@isciii.es ORCID: 0009-0006-3237-6872 5. Author Name: Jose Carlos Last name: Solana Institution: WHO Collaborating Centre for Leishmaniasis, Spanish National Center for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain Email: jc.solana@externos.isciii.es ORCID: 0000-0002-0485-6127 6. Author Name: Carmen Last name: Sánchez Institution: WHO Collaborating Centre for Leishmaniasis, Spanish National Center for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain Email: csanchezh@isciii.es ORCID: 0000-0002-6663-7325 7. Author Name: Arantxa Last name: Marco Institution: WHO Collaborating Centre for Leishmaniasis, Spanish National Center for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain Email: arantxa.marco@isciii.es ORCID: 8. Author Name: Paula Last name: Cuenca Institution: Department of Infectious Diseases, Internal Medicine, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain Email: paula.cuenca@salud.madrid.org ORCID: 9. Author Name: Juan Victor Last name: San Martín Institution: Department of Infectious Diseases, Internal Medicine, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain Email: juanvictor.san@salud.madrid.org ORCID: 10. Author Name: Filippo Last name: Lagi Institution: Infectious and Tropical Diseases Unit, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy Email: lagif@aou-careggi.toscana.it ORCID: 11. Author Name: Lorenzo Last name: Zammarchi Institution: Infectious and Tropical Diseases Unit, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy Email: lorenzo.zammarchi@unifi.it ORCID: 0000-0003-0892-8404 12. Author Name: Michele Last name: Spinicci Institution: Infectious and Tropical Diseases Unit, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy Email: michele.spinicci@unifi.it ORCID: 13. Author Name: Alessandro Last name: Bartoloni Institution: Infectious and Tropical Diseases Unit, Azienda Ospedaliero Universitaria Careggi, Firenze, Italy Email: alessandro.bartoloni@unifi.it ORCID: 14. Author Name: Bianca Last name: Granozzi Institution: Unit of Infectious Diseases, IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy Email: ORCID: 15. Author Name: Michele Last name: Bacchiega Institution: Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy Email: ORCID: 16. Author Name: Alessandra Mistral Last name: De Pascali Institution: Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy Email: alessandra.depascal3@unibo.it ORCID: 0000-0002-7982-3071 17. Author Name: Emma Last name: Balducelli Institution: Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy Email: emma.balducelli2@unibo.it ORCID: 18. Author Name: Margherita Last name: Ortalli Institution: Unit of Microbiology, IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy Email: margherita.ortalli2@unibo.it ORCID: 19. Author Name: Irene Last name: Zaghi Institution: Department of Medical and Surgical Sciences, University of Bologna, Italy Email: ORCID: 20. Author Name: Stefania Last name: Varani Institution: Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy Email: stefania.varani@unibo.it ORCID: 0000-0003-0862-4937 21. Author Name: Eugenia Last name: Carrillo Institution: WHO Collaborating Centre for Leishmaniasis, Spanish National Center for Microbiology, Instituto de Salud Carlos III, Majadahonda, Spain Email: ecarrillo@isciii.es ORCID: 0000-0002-7869-7915 -------------------------- METHODOLOGY -------------------------- 1. Methodology Cross-sectional screening study followed by longitudinal clinical follow-up of people living with HIV (PLWH) receiving antiretroviral therapy in Leishmania infantum-endemic areas of Spain and Italy. Asymptomatic infection was assessed using kDNA real-time PCR, ELISA serology, and whole blood stimulation assay (WBA) measuring IFN-γ, IL-2, and IP-10 responses. Participants with evidence of asymptomatic infection were monitored for progression to visceral leishmaniasis. 2. Software STATA version 19.5 (StataCorp, College Station, TX, USA). -------------------------- KEYWORDS -------------------------- 1. Keywords HIV; AIDS; Leishmania infantum; asymptomatic infection; surveillance; visceral leishmaniasis; whole blood stimulation assay; ELISA; PCR; immunocompromised patients; Southern Europe. -------------------------- SPONSORSHIP INFORMATION AND GRANT IDs -------------------------- 1. Grant Information This study was conducted within collaborative research activities on leishmaniasis involving the Instituto de Salud Carlos III (Spain), University of Bologna (Italy), and University of Florence (Italy). -------------------------- RELATED PUBLICATIONS -------------------------- 1. Related publication Barbiero A, Moreno J, Bernardo L, et al. The clinical significance of asymptomatic Leishmania infantum infection in people living with HIV receiving antiretroviral therapy: evidence from two southern European cohorts (manuscript under review). 2. Related dataset Dataset containing demographic, clinical, immunological, molecular, and follow-up data from 204 PLWH screened for asymptomatic Leishmania infantum infection in Spain and Italy. -------------------------- GEOGRAPHIC INFORMATION -------------------------- 1. Spatial coverage Spain (Madrid, Fuenlabrada and Majadahonda) and Italy (Florence and Bologna), all located in Leishmania infantum-endemic regions of Southern Europe. -------------------------- TEMPORAL INFORMATION -------------------------- 1. Time period coverage Participant recruitment: September 2013 to April 2023. Clinical follow-up data were collected through December 2025. -------------------------- FILES -------------------------- 1. Files Clinical dataset (.xlsx) Associated manuscript -------------------------- LICENSES AND PRIVACITY -------------------------- 1. Licenses CC BY 2. Privacity -------------------------- OTHERS -------------------------- 1. Data dictionary