Asymptomatic Leishmania Infection in HIV Patients

Terminated

• Conditions: Visceral Leishmaniasis

• Registration Number: NCT02839603
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-21
• Primary Completion: 2017-01-19
• Study Completion: 2017-01-19
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

• 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

Exclusion Criteria

• younger than 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	End of study (2 years)	Proportion of individuals with asymptomatic infection, defined as positivity on any of the leishmanial markers (PCR, urine antigen or serology)

Secondary Outcome Measures

Name	Time	Method
Proportion of asymptomatic infected patients in clinical determinant groups.	End of study (2 years)	Clinical determinant groups are constructed with key clinical characteristics and history
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
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
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)	Proportion of individuals with asymptomatic infection during follow-up, defined as positivity on any of the leishmanial markers (PCR, urine antigen or serology) amongst those without asymptomatic infection during the cross-sectional evaluation.
Proportion of individuals developing VL within the following year (= One-year risk of VL)	End of study (2 years)	VL will be diagnosed as per national guidelines.
Proportions of individuals with a positive test on a specific leishmanial marker to describe the pattern of asymptomatic infection.	End of study (2 years)

Trial Locations

Locations (1)

Metema District Hospital; 🇪🇹 Metema, Ethiopia