Predicting Visceral Leishmaniasis in HIV Infected Patients

NCT03013673 | Terminated

• 1 other identifier: ITM0915
• Study Type: observational
• Target: 566
• Locations: 1 country
• Sites: 1

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.

Conditions

Leishmaniasis, Visceral

Keywords

leishmaniasis, visceral, neglected, HIV, co-infection, asymptomatic, Ethiopia

Outcome Measures

Primary Outcomes (6)

• Prevalence of asymptomatic Leishmania infection

  The proportion of individuals with asymptomatic Leishmania infection at enrolment, among all enrolled participants

  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

  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

  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

  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

  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

  January 2021

Secondary Outcomes (4)

• Patterns in host immune markers for asymptomatic Leishmania infection

  January 2020

• Evolution of host immune markers

  January 2020

• Patterns in host immune markers for VL treatment failure

  January 2021

• Patterns in host immune markers for VL relapse

  January 2021

Study Arms (1)

HIV

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

Other: No intervention

Interventions

No intervention OTHER

No intervention

HIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• University of Gondar, Gondar, Ethiopia: collaborator
• Medecins Sans Frontieres, Netherlands: collaborator
• Bureau of Health, Abdurafi, Ethiopia: collaborator

Study Sites (1)

Abdurafi Health Center

Ābderafī, Amhara, Ethiopia

Location

Biospecimen

Retention: SAMPLES WITH DNA

All samples and sample left-overs (blood and urine) not used during the course of this study will be stored for 25 years after the end of the study.

MeSH Terms

Conditions

Leishmaniasis, Visceral; Leishmaniasis; Coinfection

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Johan van Griensven, MD PhD

  Institute of Tropical Medicine, Antwerp, Belgium

  STUDY CHAIR

• Ermias Diro, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 6, 2017
• Study Start: October 11, 2017
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

ET (1)