Recurrent visceral leishmaniasis in people living with HIV
New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Tropical Medicine, Belgium Academic / other |
| Locations | 1 site (Gonder) |
| Trial ID | NCT07487350 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gonder
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.