Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:49 PM
Study NCT ID:
NCT07487350
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recurrent Visceral Leishmaniasis in HIV Co-Infection
Sponsor:
Institute of Tropical Medicine, Belgium
Organization:
Study Overview
Official Title:
New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALIVE
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: