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NCT Number: NCT07487350

Recurrent Visceral Leishmaniasis in HIV Co-Infection

The aim is (1) to better understand the underlying causes and predispositions for relapse and parasite persistence in visceral leishmaniasis (VL) patients living with HIV and (2) to improve treatment monitoring of this target group in Ethiopia

Recruiting

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Euglenozoa Infections Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Leishmaniasis Leishmaniasis, Visceral Lentivirus Infections Parasitic Diseases Protozoan Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vector Borne Diseases Virus Diseases Visceral Leishmaniasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Prospective and retrospective observational cohort study

Main objective

  • To identify the key host and pathogen factors that contribute to active chronicity (=recurrent or chronic parasite presence in blood, tissue and/or skin in combination with clinical symptoms) in VL/HIV patients in northern Ethiopia

Specific objectives

  • To describe the VL/HIV patients by level of chronicity using routine clinical and laboratory data
  • To monitor parasite presence by molecular diagnostic in peripheral blood and - if available - tissue aspirates before, during, after treatment as well as during follow-up by level of disease chronicity
  • To broadly characterize the underlying HIV co-infection and potential of ART resistance by level of disease chronicity
  • To genotype the Leishmania parasites by level of disease chronicity to assess re-infection, recrudescence, drug resistance, and quiescence/virulence
  • To identify other concomitant (latent) co-infections (TB, malaria, intestinal helminths, viral infections) and its impact on disease chronicity
  • To study the level of exhaustion and immune checkpoint inhibition pathways, as potential therapy targets, by disease chronicity
  • To assess the quality of life by a standardised questionnaire at admission and during follow-up

Exploratory objective:

  • To study the persistence and quantity of parasites within the skin
  • To study the stool microbiome of VL-HIV patients
  • To assess the potential impact of secondary prophylaxis on relapse frequency, relapse intervals, relapse intensity, and exhaustion marker (compared with historical cohort/patients without secondary prophylaxis)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • VL-HIV infection 1.1. VL: microscopically confirmed parasite presence in spleen or bone marrow tissue at first episode or relapse; for known active chronic cases: decision to treat VL 1.2. HIV: confirmed viral infection (new or past)
  • ≥18 years

Exclusion criteria

  • Not willing to provide written informed consent
  • Not willing to adhere to the follow-up visits
  • Mentally or physically incapable to participate in the study (to the discretion of the treating physician)

Treatment and study plan

Primary outcomes

  1. key host and pathogen factors of active chronicity in VL/HIV patients

    Time frame: 12 months

    Descriptive analysis of key host and pathogen factors that contribute to active chronicity in VL/HIV patients in northern Ethiopia

Study contacts

Contact information is provided by the study sponsor or research team.

Johan van Griensven

CONTACT

[email protected]

Nicole Berens-Riha

CONTACT

[email protected]

0460850115

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Armauer Hansen Research Institute, Ethiopia
  • University of Gondar

Registry information

Official study title

New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study

Acronym: ALIVE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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