Actively Recruiting
New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study
Led by Institute of Tropical Medicine, Belgium · Updated on 2026-03-23
20
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
I
Institute of Tropical Medicine, Belgium
Lead Sponsor
A
Armauer Hansen Research Institute, Ethiopia
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Recurrent Visceral Leishmaniasis in HIV Co-Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed visceral leishmaniasis by parasite presence in spleen or bone marrow tissue at first episode or relapse, or decision to treat for known chronic cases
- Confirmed HIV infection (new or past)
- Age 18 years or older
You will not qualify if you...
- Unwilling to provide written informed consent
- Unwilling to attend follow-up visits
- Mentally or physically unable to participate as judged by the treating physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo diagnostic procedures to confirm visceral leishmaniasis and HIV co-infection, including parasite detection in tissue and blood samples.
1 to 2 visits depending on specimen availability
Duration - Up to 12 months
Participants are monitored over time to assess parasite presence, disease chronicity, co-infections, immune response, and quality of life through routine clinical and laboratory assessments.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
University of Gondar
Gonder, Ethiopia
Actively Recruiting
Research Team
N
Nicole Berens-Riha
J
Johan van Griensven
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here