Clinical trial NCT03013673: Predicting Visceral Leishmaniasis in HIV Infected Patients
Official title: Predicting Visceral Leishmaniasis in HIV Infected Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Leishmaniasis, Visceral
Keywords: leishmaniasis, visceral, neglected, HIV, co-infection, asymptomatic, Ethiopia
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: University of Gondar, Gondar, Ethiopia
name: Medecins Sans Frontieres, Netherlands
name: Bureau of Health, Abdurafi, Ethiopia
First posted: 2017-01-06
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected individuals residing in VL-endemic areas in Northern Ethiopia

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Confirmed HIV-positive
* Enrolled in HIV care at the study site

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Prevalence of asymptomatic Leishmania infection
timeFrame: January 2018
measure: Incidence rate of asymptomatic Leishmania infection
timeFrame: January 2020
measure: Evolution of Leishmania infection markers
timeFrame: January 2020
measure: Incidence rate of active VL
timeFrame: January 2020
measure: Risk factors for active VL
timeFrame: January 2020
measure: Prognostic tool for active VL
timeFrame: January 2021
Secondary outcomes:
measure: Patterns in host immune markers for asymptomatic Leishmania infection
timeFrame: January 2020
measure: Evolution of host immune markers
timeFrame: January 2020
measure: Patterns in host immune markers for VL treatment failure
timeFrame: January 2021
measure: Patterns in host immune markers for VL relapse
timeFrame: January 2021
Other outcomes:
Locations:
city: Abderafi
country: Ethiopia
facility: Abdurafi Health Center
state: Amhara
Study officials:
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Johan van Griensven, MD PhD
role: STUDY_CHAIR
affiliation: College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
name: Ermias Diro, MD
role: STUDY_DIRECTOR
References: