Leishmaniasis, VisceralPreLeisHNCT03013673
Predicting Visceral Leishmaniasis in HIV Infected Patients
An observational study of Leishmaniasis, Visceral, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
Trial summary
In this cohort study, the investigators will study the asymptomatic period preceding the onset of active Visceral Leishmaniasis (VL) in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leishmaniasis, Visceral
- How many people
- 566 participants
- Where
- 1 siteEthiopia
- Study dates
- 11 Oct 2017to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: HIV-infected individuals residing in VL-endemic areas in Northern Ethiopia
Who may be able to join
- Confirmed HIV-positive
- Enrolled in HIV care at the study site
Who cannot join
- Age under 18 years
- Diagnosis of active Visceral Leishmaniasis at enrolment
- Unlikely to seek health care again at this site during the next two years
- Not able or willing to provide informed consent. For patients not able to provide informed consent: No guardian available or willing to provide IC
- Medical emergency, underlying chronic medical condition, or other circumstances that make adherence to the study unlikely, or participation in the study medically inadvisable.
Trial locations and contacts
1 site in 1 country.
About this study
In this cohort study, the investigators will study the asymptomatic period preceding the onset of active Visceral Leishmaniasis (VL) in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL.
Read the detailed description
HIV co-infection drastically increases the risk of developing active VL. Clinical outcomes are dire in immune-compromised patients even with the best available treatment, and relapse is frequent. The incubation period may provide an important window of opportunity for a pre-emptive "screen an treat" approach in HIV co-infected patients to prevent progression from infection to the active disease. However, no recommendations exist to date due to lack of solid evidence.
It is not known which patients are at highest risk of disease progression, which role parasite/host/HIV factors play in the asymptomatic infection phase, and what the diagnostic values of existing Leishmania infection markers are. Such information is needed to develop a prognostic clinical tool for the detection of HIV patients at high risk of developing active VL.
Therefore, the aim is to study the asymptomatic period preceding the onset of active VL in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL. This will be a prospective cohort study with one year of follow-up for patients who remain VL free. Patients developing active VL during the study period will be followed until the end of the study duration.
- Conditions
- Leishmaniasis, Visceral
- Being tested
- No intervention
- Keywords
- leishmaniasis, visceral, neglected, HIV, co-infection, asymptomatic, Ethiopia
- Medical subject headings
- Leishmaniasis, Visceral, Leishmaniasis, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| HIV | HIV infected individuals residing in VL-endemic areas in Northern Ethiopia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of asymptomatic Leishmania infection
The proportion of individuals with asymptomatic Leishmania infection at enrolment, among all enrolled participants
Measured: January 2018
Incidence rate of asymptomatic Leishmania infection
The number of individuals with newly diagnosed asymptomatic Leishmania infection per person-years at risk during follow-up, among participants without Leishmania infection at enrolment
Measured: January 2020
Evolution of Leishmania infection markers
The proportions of individuals with positive test results for the different Leishmania infection markers at each follow-up visit
Measured: January 2020
Incidence rate of active VL
The number of individuals who develop active VL per person-years at risk during follow-up, among all enrolled participants
Measured: January 2020
Risk factors for active VL
The association between the risk to develop active VL during follow-up and demographic/clinical characteristics as well as HIV/host immunity/Leishmania infection markers from baseline onwards
Measured: January 2020
Prognostic tool for active VL
A clinical decision algorithm, prioritizing and integrating identified risk factors, that is able to most efficiently predict the risk of developing active VL within 12 months
Measured: January 2021
Secondary outcomes (4)
Patterns in host immune markers for asymptomatic Leishmania infection
The association between asymptomatic Leishmania infection and the levels of the different host immune markers, among participants tested for host immune markers
Measured: January 2020
Evolution of host immune markers
The average levels of the different host immune markers at each follow-up visit
Measured: January 2020
Patterns in host immune markers for VL treatment failure
The association between the risk of VL treatment failure and the levels and evolution of the different host immune markers, among participants who develop active VL and receive VL treatment
Measured: January 2021
Patterns in host immune markers for VL relapse
The association between the risk of VL relapse and the levels and evolution of the different host immune markers, among participants who develop active VL
Measured: January 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start11 Oct 2017
- Primary completion31 May 2021
- Study completion31 May 2021
Why it stopped: Due to the ongoing conflict in the Tigray region
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leishmaniasis, VisceralStudies 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
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gondar, Medecins Sans Frontieres, Netherlands, Bureau of Health, Abdurafi, Ethiopia
- Responsible party
- Sponsor
- Investigators
- Johan van Griensven, MD PhD, Study chair, Institute of Tropical Medicine, Antwerp, BelgiumErmias Diro, MD, Study director, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013673
- Sponsor's protocol ID
- ITM0915
- Acronym
- PreLeisH
- Status last verified
- Sep 2022
- First submitted
- 5 Jan 2017
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Diro E, Ritmeijer K, van Henten S, Kibret A, Kassa M, Beyene H, Adriaensen W, Pareyn M, van Griensven J. A Diagnostic Algorithm Based on Urine Antigen and Blood Polymerase Chain Reaction Testing for Visceral Leishmaniasis in HIV-Coinfected Patients in Northwest Ethiopia. Am J Trop Med Hyg. 2026 Sep 15:tpmd260104. doi: 10.4269/ajtmh.26-0104. Online ahead of print.
PubMed 42743918
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Visceral Leishmaniasis in HIV Infected Patients
- ClinicalTrials.gov ID
- NCT03013673
- Acronym / sponsor ID
- PreLeisH / ITM0915
- Conditions
- Leishmaniasis, Visceral
- Keywords
- leishmaniasis, visceral, neglected, HIV, co-infection, asymptomatic, Ethiopia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the ongoing conflict in the Tigray region
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University of Gondar, Medecins Sans Frontieres, Netherlands, Bureau of Health, Abdurafi, Ethiopia
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
In this cohort study, the investigators will study the asymptomatic period preceding the onset of active Visceral Leishmaniasis (VL) in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL.
Detailed description
HIV co-infection drastically increases the risk of developing active VL. Clinical outcomes are dire in immune-compromised patients even with the best available treatment, and relapse is frequent. The incubation period may provide an important window of opportunity for a pre-emptive "screen an treat" approach in HIV co-infected patients to prevent progression from infection to the active disease. However, no recommendations exist to date due to lack of solid evidence.
It is not known which patients are at highest risk of disease progression, which role parasite/host/HIV factors play in the asymptomatic infection phase, and what the diagnostic values of existing Leishmania infection markers are. Such information is needed to develop a prognostic clinical tool for the detection of HIV patients at high risk of developing active VL.
Therefore, the aim is to study the asymptomatic period preceding the onset of active VL in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL. This will be a prospective cohort study with one year of follow-up for patients who remain VL free. Patients developing active VL during the study period will be followed until the end of the study duration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV | – | Other: No interventionHIV infected individuals residing in VL-endemic areas in Northern Ethiopia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected individuals residing in VL-endemic areas in Northern Ethiopia
Key inclusion criteria (2 listed)
- Confirmed HIV-positive
- Enrolled in HIV care at the study site
Key exclusion criteria (5 listed)
- Age under 18 years
- Diagnosis of active Visceral Leishmaniasis at enrolment
- Unlikely to seek health care again at this site during the next two years
- Not able or willing to provide informed consent. For patients not able to provide informed consent: No guardian available or willing to provide IC
- Medical emergency, underlying chronic medical condition, or other circumstances that make adherence to the study unlikely, or participation in the study medically inadvisable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | HIV |
Primary outcome
Prevalence of asymptomatic Leishmania infection
Time frame: January 2018
The proportion of individuals with asymptomatic Leishmania infection at enrolment, among all enrolled participants
Incidence rate of asymptomatic Leishmania infection
Time frame: January 2020
The number of individuals with newly diagnosed asymptomatic Leishmania infection per person-years at risk during follow-up, among participants without Leishmania infection at enrolment
Evolution of Leishmania infection markers
Time frame: January 2020
The proportions of individuals with positive test results for the different Leishmania infection markers at each follow-up visit
Incidence rate of active VL
Time frame: January 2020
The number of individuals who develop active VL per person-years at risk during follow-up, among all enrolled participants
Risk factors for active VL
Time frame: January 2020
The association between the risk to develop active VL during follow-up and demographic/clinical characteristics as well as HIV/host immunity/Leishmania infection markers from baseline onwards
Prognostic tool for active VL
Time frame: January 2021
A clinical decision algorithm, prioritizing and integrating identified risk factors, that is able to most efficiently predict the risk of developing active VL within 12 months
4 secondary outcomes
Patterns in host immune markers for asymptomatic Leishmania infection
Time frame: January 2020
Evolution of host immune markers
Time frame: January 2020
Patterns in host immune markers for VL treatment failure
Time frame: January 2021
Patterns in host immune markers for VL relapse
Time frame: January 2021
Results and safety
The study was stopped early (reason given: Due to the ongoing conflict in the Tigray region). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Derived from this study: PubMed 42743918Diro E, Ritmeijer K, van Henten S, Kibret A, Kassa M, Beyene H, Adriaensen W, Pareyn M, van Griensven J. A Diagnostic Algorithm Based on Urine Antigen and Blood Polymerase Chain Reaction Testing for Visceral Leishmaniasis in HIV-Coinfected Patients in Northwest Ethiopia. Am J Trop Med Hyg. 2026 Sep 15:tpmd260104. doi: 10.4269/ajtmh.26-0104. Online ahead of print.
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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. This study is not recruiting at the moment.
Johan van Griensven, MD PhD study chair
Institute of Tropical Medicine, Antwerp, Belgium
Ermias Diro, MD study director
College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
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 Leishmaniasis, Visceral, 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 5 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: stopped early, as of the sponsor's last update on 9 Sep 2022. 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?
The study was stopped early (reason given: Due to the ongoing conflict in the Tigray region). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of asymptomatic Leishmania infection (time frame: January 2018). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03013673, which also lists 1 linked publication.
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 9 Sep 2022.