Asymptomatic Leishmania Infection in HIV Patients

NCT02839603 | Terminated

• 1 other identifier: 920/13
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

To collect pilot data on the prevalence and incidence of asymptomatic Leishmania donovani infection in HIV infected individuals in a visceral leishmaniasis (VL)-HIV endemic region to inform the feasibility of a larger study exploring a screen and treat strategy for VL in HIV co-infected individuals in East-Africa (Ethiopia).

Conditions

Visceral Leishmaniasis

Keywords

Visceral leishmaniasis; HIV co-infection; Asymptomatic

Outcome Measures

Primary Outcomes (1)

• The proportion of individuals with L.donovani asymptomatic infection at baseline in HIV coinfected adults enrolled in HIV care in a VL-HIV endemic region in North-West Ethiopia.

  Proportion of individuals with asymptomatic infection, defined as positivity on any of the leishmanial markers (PCR, urine antigen or serology)

  End of study (2 years)

Secondary Outcomes (6)

• The proportion of individuals with asymptomatic infection during follow-up in HIV coinfected adults enrolled in HIV care in a VL-HIV endemic region in North-West Ethiopia

  End of study (2 years)

• Proportions of individuals with a positive test on a specific leishmanial marker to describe the pattern of asymptomatic infection.

  End of study (2 years)

• Proportion of asymptomatic infected patients in clinical determinant groups.

  End of study (2 years)

• Total proportion of baseline asymptomatic infected patients, with positive infection status at 3, 6, 9 and 12 months follow-up.

  3, 6, 9 and 12 months of follow-up

• Proportion of baseline asymptomatic infected patients, with positive infection status for each baseline leishmanial marker at 3, 6, 9 and 12 months

  3, 6, 9 and 12 months of follow-up

Eligibility Criteria

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

Study Population

Adult individuals enrolled in HIV care in Metema hospital

You may qualify if:

• HIV infection
• without a history of VL in the last 5 years
• stable residents of a VL-endemic area
• willing to participate and giving free informed consent

You may not qualify if:

• younger than 18 years

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• University of Gondar: collaborator
• Addis Ababa University: collaborator
• Metema District Hospital, Metema, Ethiopia: collaborator

Study Sites (1)

Metema District Hospital

Metemma, Ethiopia

Location

Related Publications (1)

• van Griensven J, van Henten S, Mengesha B, Kassa M, Adem E, Endris Seid M, Abdellati S, Asefa W, Simegn T, Debasu D, Bogale T, Gedamu Y, Van Den Bossche D, Adriaensen W, Van der Auwera G, Cnops L, Vogt F, Diro E. Longitudinal evaluation of asymptomatic Leishmania infection in HIV-infected individuals in North-West Ethiopia: A pilot study. PLoS Negl Trop Dis. 2019 Oct 8;13(10):e0007765. doi: 10.1371/journal.pntd.0007765. eCollection 2019 Oct.

  PMID: 31593563 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum Plasma Whole blood Urine Stool

MeSH Terms

Conditions

Leishmaniasis, Visceral

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Design

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

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 21, 2016
• Study Start: September 1, 2015
• Primary Completion: January 19, 2017
• Study Completion: January 19, 2017
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)