Recurrent Visceral Leishmaniasis in HIV Co-Infection

NCT07487350 | Recruiting

• 1 other identifier: 1926/25
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hiv; Visceral Leishmaniasis

Keywords

HIV; VL; VL Relapse; Immune exhaustion

Outcome Measures

Primary Outcomes (1)

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

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

  12 months

Eligibility Criteria

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

Study Population

All HIV co-infected patients prospectively diagnosed with VL (either first infection or relapse) and known HIV co-infected patients recruited in previous studies

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Armauer Hansen Research Institute, Ethiopia: collaborator
• University of Gondar: collaborator

Study Sites (1)

University of Gondar

Gonder, Ethiopia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue (spleen/bone marrow) collection for parasite DNA and viral RNA

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Leishmaniasis, Visceral

Condition Hierarchy (Ancestors)

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

Study Officials

• Eleni Ayele

  LRTC University of Gondar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Berens-Riha

CONTACT

0460850115; nberens@itg.be

Johan van Griensven

CONTACT

jvangriensven@itg.be

Study Design

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

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: October 21, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)