HivALIVENCT07487350
Recurrent Visceral Leishmaniasis in HIV Co-Infection
An observational study of Hiv and Visceral Leishmaniasis, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Visceral Leishmaniasis
- How many people
- 20 participants
- Where
- 1 siteEthiopia
- Study dates
- 21 Oct 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johan van Griensven contact
Ethiopia1 site, 1 recruiting
- Recruiting
University of Gondar
Gonder
Eleni Ayele, eleniayele2@gmail.com
Mezgebu Asres, msilamsaw@gmail.com
About this study
Official title: 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
Read the 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)
- Conditions
- Hiv, Visceral Leishmaniasis
- Keywords
- HIV, VL, VL Relapse, Immune exhaustion
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Leishmaniasis, Visceral
What is being measured
The primary outcome is the main question the study is designed to answer.
key host and pathogen factors of active chronicity in VL/HIV patients
Descriptive analysis of key host and pathogen factors that contribute to active chronicity in VL/HIV patients in northern Ethiopia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start21 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia, University of Gondar
- Responsible party
- Sponsor
- Investigators
- Eleni Ayele, Principal investigator, LRTC University of Gondar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487350
- Sponsor's protocol ID
- 1926/25
- Acronym
- ALIVE
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Vulnerable patients, individual participant data will not be shared. Only anonymized accumulated data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study
- ClinicalTrials.gov ID
- NCT07487350
- Acronym / sponsor ID
- ALIVE / 1926/25
- Conditions
- Hiv, Visceral Leishmaniasis
- Keywords
- HIV, VL, VL Relapse, Immune exhaustion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Armauer Hansen Research Institute, Ethiopia, University of Gondar
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No. Vulnerable patients, individual participant data will not be shared. Only anonymized accumulated data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johan van Griensven contact
Eleni Ayele principal investigator
LRTC University of Gondar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Visceral Leishmaniasis, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Berens-Riha (0460850115, nberens@itg.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
key host and pathogen factors of active chronicity in VL/HIV patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.