Recurrent Visceral Leishmaniasis in HIV Co-Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hiv, Visceral Leishmaniasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ethiopia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study
Overview
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
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)
Primary outcome measures
- key host and pathogen factors of active chronicity in VL/HIV patients [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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)
- ≥18 years
Exclusion criteria
- Not willing to provide written informed consent
- Not willing to adhere to the follow-up visits
- Mentally or physically incapable to participate in the study (to the discretion of the treating physician)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ethiopia · 1 center
- University of Gondar — Gonder
Identifiers
NCT: NCT07487350 · 1926/25