Clinical Trials

MainTitle

Asymptomatic Leishmania Infection in HIV Patients

This study has been terminated
( Aim to assess feasibility achieved, larger project starting earlier than anticipated )

Sponsor
Institute of Tropical Medicine, Belgium

Collaborator
University of Gondar
Addis Ababa University
Metema District Hospital, Metema, Ethiopia

Information provided by (Responsible Party)
Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier
NCT02839603

First received: July 12, 2016
Last updated: August 28, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

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).

Condition
Visceral Leishmaniasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Asymptomatic Leishmania Infection and Burden of Visceral Leishmaniasis in HIV-infected Individuals in North West Ethiopia: a Pilot Study

Further study details as provided by Institute of Tropical Medicine, Belgium:

Primary Outcome Measures

  • 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. [ Time Frame: 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:
  • 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 [ Time Frame: 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.
  • Proportions of individuals with a positive test on a specific leishmanial marker to describe the pattern of asymptomatic infection. [ Time Frame: End of study (2 years) ]
  • Proportion of asymptomatic infected patients in clinical determinant groups. [ Time Frame: End of study (2 years) ]
    Clinical determinant groups are constructed with key clinical characteristics and history
  • Total proportion of baseline asymptomatic infected patients, with positive infection status at 3, 6, 9 and 12 months follow-up. [ Time Frame: 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 [ Time Frame: 3, 6, 9 and 12 months of follow-up ]
  • Proportion of individuals developing VL within the following year (= One-year risk of VL) [ Time Frame: End of study (2 years) ]
    VL will be diagnosed as per national guidelines.

Biospecimen Retention: Samples With DNA
Serum Plasma Whole blood Urine Stool

Enrollment: 540
Study Start Date: September 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Probability Sample  

Study Population

Adult individuals enrolled in HIV care in Metema hospital

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02839603

Locations

Ethiopia
Metema District Hospital
Metema, Ethiopia

Sponsors and Collaborators

Institute of Tropical Medicine, Belgium
University of Gondar
Addis Ababa University
Metema District Hospital, Metema, Ethiopia
More Information

More Information


Responsible Party: Institute of Tropical Medicine, Belgium  
ClinicalTrials.gov Identifier: NCT02839603   History of Changes  
Other Study ID Numbers: 920/13  
Study First Received: July 12, 2016  
Last Updated: August 28, 2017  

Keywords provided by Institute of Tropical Medicine, Belgium:

Visceral leishmaniasis
HIV co-infection
Asymptomatic

Additional relevant MeSH terms:
Infection
Leishmaniasis
Leishmaniasis, Visceral

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.