Recurrent visceral leishmaniasis in people living with HIV
Official title: New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study
Run by Institute of Tropical Medicine, Belgium · NCT07487350 · Data updated 2026-11-12
This project will follow adults living with HIV who develop visceral leishmaniasis to see if differences in the patient or the parasite explain why some people have repeated relapses.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Institute of Tropical Medicine, Belgium Academic / other |
| Locations | 1 site (Gonder) |
| Status | Recruiting |
| Started | October 21, 2025 |
| Main results expected | April 2027 |
| Study ends | December 2027 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT07487350 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) in northern Ethiopia with confirmed visceral leishmaniasis and documented HIV infection who can give informed consent and attend follow-up visits are the ideal candidates.
✕Probably not a fit
People under 18, those without confirmed VL or HIV, or individuals unwilling or unable to provide consent or adhere to follow-up visits are not eligible and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective and retrospective observational cohort will enroll adults with confirmed VL and HIV at the University of Gondar and follow them through treatment and scheduled follow-up visits. Researchers will use routine clinical data, molecular diagnostics on blood and available tissue aspirates, parasite genotyping, and immune profiling to classify patients by level of disease chronicity. The study will also screen for other co-infections, measure quality of life, and explore skin parasite persistence and the stool microbiome as exploratory endpoints. Collected data aim to link host, pathogen, and environmental factors with relapse risk and possible immune-exhaustion pathways that could become treatment targets.
Why it matters
Potential benefit: If successful, the work could improve prediction and monitoring of relapse, guide targeted follow-up, and identify biological targets for new therapies or prophylaxis in VL/HIV patients.
How similar studies have gone: Previous research has documented high relapse rates and identified some host and parasite risk factors in VL/HIV, but comprehensive molecular, genotypic and immune-exhaustion profiling in this population—especially in Ethiopia—remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. VL-HIV infection 1.1. VL: microscopically confirmed parasite presence in spleen or bone marrow tissue at first episode or relapse; for known active chronic cases: decision to treat VL 1.2. HIV: confirmed viral infection (new or past) 2. ≥18 years Exclusion Criteria: 1. Not willing to provide written informed consent 2. Not willing to adhere to the follow-up visits 3. Mentally or physically incapable to participate in the study (to the discretion of the treating physician)
Where it's running
-
University of Gondar
Gonder, Ethiopia Recruiting
Study contacts
- Principal investigator: Eleni Ayele — LRTC University of Gondar
- Study coordinator: Nicole Berens-Riha
- Email: nberens@itg.be
- Phone: 0460850115
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.