Visceral LeishmaniasisNCT02839603
Asymptomatic Leishmania Infection in HIV Patients
An observational study of Visceral Leishmaniasis, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visceral Leishmaniasis
- How many people
- 540 participants
- Where
- 1 siteEthiopia
- Study dates
- Sep 2015to 19 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult individuals enrolled in HIV care in Metema hospital
Who may be able to join
- 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
Who cannot join
- younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Asymptomatic Leishmania Infection and Burden of Visceral Leishmaniasis in HIV-infected Individuals in North West Ethiopia: a Pilot Study
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
- Medical subject headings
- Leishmaniasis, Visceral
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: End of study (2 years)
Proportions of individuals with a positive test on a specific leishmanial marker to describe the pattern of asymptomatic infection.
Measured: End of study (2 years)
Proportion of asymptomatic infected patients in clinical determinant groups.
Clinical determinant groups are constructed with key clinical characteristics and history
Measured: 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.
Measured: 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
Measured: 3, 6, 9 and 12 months of follow-up
Proportion of individuals developing VL within the following year (= One-year risk of VL)
VL will be diagnosed as per national guidelines.
Measured: End of study (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startSep 2015
- Primary completion19 Jan 2017
- Study completion19 Jan 2017
Why it stopped: Aim to assess feasibility achieved, larger project starting earlier than anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visceral LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gondar, Addis Ababa University, Metema District Hospital, Metema, Ethiopia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839603
- Sponsor's protocol ID
- 920/13
- Status last verified
- Oct 2018
- First submitted
- 12 Jul 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31593563
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic Leishmania Infection and Burden of Visceral Leishmaniasis in HIV-infected Individuals in North West Ethiopia: a Pilot Study
- ClinicalTrials.gov ID
- NCT02839603
- Acronym / sponsor ID
- 920/13
- Conditions
- Visceral Leishmaniasis
- Keywords
- Visceral leishmaniasis, HIV co-infection, Asymptomatic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Aim to assess feasibility achieved, larger project starting earlier than anticipated
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University of Gondar, Addis Ababa University, Metema District Hospital, Metema, Ethiopia
- Study start
- Sep 2015
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult individuals enrolled in HIV care in Metema hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
6 secondary outcomes
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)
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)
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)
Results and safety
The study was stopped early (reason given: Aim to assess feasibility achieved, larger project starting earlier than anticipated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 31593563van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Leishmaniasis, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Aim to assess feasibility achieved, larger project starting earlier than anticipated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02839603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.