Recurrent Visceral Leishmaniasis in HIV Co-Infection

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07487350

Acronym

ALIVE

Enrollment

Registered

2026-03-23

Start date

2025-10-21

Completion date

2027-12-01

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv, Visceral Leishmaniasis

Keywords

HIV, VL, VL Relapse, Immune exhaustion

Brief summary

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

Ethiopia

Contacts

CONTACTNicole Berens-Riha

nberens@itg.be0460850115

CONTACTJohan van Griensven

jvangriensven@itg.be

PRINCIPAL_INVESTIGATOREleni Ayele

LRTC University of Gondar

Outcome results