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Predicting Visceral Leishmaniasis in HIV Infected Patients (PreLeisH)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by Institute of Tropical Medicine, Belgium
Sponsor:
Collaborators:
University of Gondar, Gondar, Ethiopia
Medecins Sans Frontieres, Netherlands
Bureau of Health, Abdurafi, Ethiopia
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier:
NCT03013673
First received: January 5, 2017
Last updated: January 6, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Leishmaniasis, Visceral
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Visceral Leishmaniasis in HIV Infected Patients

Resource links provided by NLM:


Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Patterns in host immune markers for asymptomatic Leishmania infection [ Time Frame: January 2020 ]
    The association between asymptomatic Leishmania infection and the levels of the different host immune markers, among participants tested for host immune markers

  • Evolution of host immune markers [ Time Frame: January 2020 ]
    The average levels of the different host immune markers at each follow-up visit

  • Patterns in host immune markers for VL treatment failure [ Time Frame: January 2021 ]
    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

  • Patterns in host immune markers for VL relapse [ Time Frame: January 2021 ]
    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


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.

Estimated Enrollment: 1045
Study Start Date: March 2017
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV
HIV infected individuals residing in VL-endemic areas in Northern Ethiopia
Other: No intervention

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 two years of follow-up for patients who remain VL free. Patients developing active VL during the study period will be followed for one year after disease onset.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected individuals residing in VL-endemic areas in Northern Ethiopia
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03013673

Contacts
Contact: Johan van Griensven, MD PhD +3232476476 jvangriensven@itg.be
Contact: Ermias Diro, MD +251911670953 ermi_diro@yahoo.com

Locations
Ethiopia
Abdurafi Health Center Not yet recruiting
Abderafi, Amhara, Ethiopia
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
University of Gondar, Gondar, Ethiopia
Medecins Sans Frontieres, Netherlands
Bureau of Health, Abdurafi, Ethiopia
Investigators
Study Chair: Johan van Griensven, MD PhD Institute of Tropical Medicine, Antwerp, Belgium
Study Director: Ermias Diro, MD College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
  More Information

Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT03013673     History of Changes
Other Study ID Numbers: ITM0915
Study First Received: January 5, 2017
Last Updated: January 6, 2017

Keywords provided by Institute of Tropical Medicine, Belgium:
leishmaniasis, visceral, neglected, HIV, co-infection, asymptomatic, Ethiopia

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on March 24, 2017