Predicting Visceral Leishmaniasis in HIV Infected Patients

NCT ID: NCT03013673

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 566 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-11
• Study Completion Date: 2021-05-31

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.

Conditions

Leishmaniasis, Visceral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV

HIV infected individuals residing in VL-endemic areas in Northern Ethiopia

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Gondar, Gondar, Ethiopia

UNKNOWN

Sponsor Role: collaborator

Medecins Sans Frontieres, Netherlands

OTHER

Sponsor Role: collaborator

Bureau of Health, Abdurafi, Ethiopia

UNKNOWN

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johan van Griensven, MD PhD

Role: STUDY_CHAIR

Institute of Tropical Medicine, Antwerp, Belgium

Ermias Diro, MD

Role: STUDY_DIRECTOR

College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia

Locations

Abdurafi Health Center

Ābderafī, Amhara, Ethiopia

Countries

Ethiopia

Other Identifiers

ITM0915

Identifier Type: -

Identifier Source: org_study_id