Recurrent Visceral Leishmaniasis in HIV Co-Infection (ALIVE)

March 17, 2026 updated by: Institute of Tropical Medicine, Belgium

New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study

The aim is (1) to better understand the underlying causes and predispositions for relapse and parasite persistence in visceral leishmaniasis (VL) patients living with HIV and (2) to improve treatment monitoring of this target group in Ethiopia

Study Overview

Status

Recruiting

Conditions

Detailed Description

Prospective and retrospective observational cohort study

Main objective

- To identify the key host and pathogen factors that contribute to active chronicity (=recurrent or chronic parasite presence in blood, tissue and/or skin in combination with clinical symptoms) in VL/HIV patients in northern Ethiopia

Specific objectives

  • To describe the VL/HIV patients by level of chronicity using routine clinical and laboratory data
  • To monitor parasite presence by molecular diagnostic in peripheral blood and - if available - tissue aspirates before, during, after treatment as well as during follow-up by level of disease chronicity
  • To broadly characterize the underlying HIV co-infection and potential of ART resistance by level of disease chronicity
  • To genotype the Leishmania parasites by level of disease chronicity to assess re-infection, recrudescence, drug resistance, and quiescence/virulence
  • To identify other concomitant (latent) co-infections (TB, malaria, intestinal helminths, viral infections) and its impact on disease chronicity
  • To study the level of exhaustion and immune checkpoint inhibition pathways, as potential therapy targets, by disease chronicity
  • To assess the quality of life by a standardised questionnaire at admission and during follow-up

Exploratory objective:

  • To study the persistence and quantity of parasites within the skin
  • To study the stool microbiome of VL-HIV patients
  • To assess the potential impact of secondary prophylaxis on relapse frequency, relapse intervals, relapse intensity, and exhaustion marker (compared with historical cohort/patients without secondary prophylaxis)

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nicole Berens-Riha
  • Phone Number: 0460850115
  • Email: nberens@itg.be

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All HIV co-infected patients prospectively diagnosed with VL (either first infection or relapse) and known HIV co-infected patients recruited in previous studies

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
key host and pathogen factors of active chronicity in VL/HIV patients
Time Frame: 12 months
Descriptive analysis of key host and pathogen factors that contribute to active chronicity in VL/HIV patients in northern Ethiopia
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Tropical Medicine, Belgium

Collaborators

Armauer Hansen Research Institute, Ethiopia
University of Gondar

Investigators

  • Principal Investigator: Eleni Ayele, LRTC University of Gondar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1926/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Vulnerable patients, individual participant data will not be shared. Only anonymized accumulated data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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