Asymptomatic Leishmania Infection in HIV Patients

Visceral Leishmaniasis Clinical Trial

Official title:

Asymptomatic Leishmania Infection and Burden of Visceral Leishmaniasis in HIV-infected Individuals in North West Ethiopia: a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02839603
• Other study ID #: 920/13
• Status: Terminated
• Start date: September 2015
• Est. completion date: January 19, 2017

Study information

• Verified date: October 2018
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 540
• Est. completion date: January 19, 2017
• Est. primary completion date: January 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Leishmaniasis
• Leishmaniasis, Visceral
• Visceral Leishmaniasis

Locations

Country	Name	City	State
Ethiopia	Metema District Hospital	Metema

Sponsors (4)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Addis Ababa University, Metema District Hospital, Metema, Ethiopia, University of Gondar

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	End of study (2 years)
Secondary	Proportions of individuals with a positive test on a specific leishmanial marker to describe the pattern of asymptomatic infection.		End of study (2 years)
Secondary	Proportion of asymptomatic infected patients in clinical determinant groups.	Clinical determinant groups are constructed with key clinical characteristics and history	End of study (2 years)
Secondary	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
Secondary	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
Secondary	Proportion of individuals developing VL within the following year (= One-year risk of VL)	VL will be diagnosed as per national guidelines.	End of study (2 years)