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Determining whether a less invasive blood test, skin test and a non-invasive urine test can be used to diagnose Kala Azar and whether they can also be used as a test of cure

Evaluation of qPCR, peripheral blood buffy coat smear and urine antigen ELISA for diagnosis and test of cure for visceral leishmaniasis in HIV co-infected patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/03/017908
Enrollment
73
Registered
2019-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A00-B99- Certain infectious and parasitic diseases

Interventions

None listed

Sponsors

Liverpool School of Tropical Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis of HIV as per National AIDS control organization (NACO) guidelines 18 years of age or over Given written consent Diagnosis of VL (clinical examination and parasitological confirmation)

Exclusion criteria

Exclusion criteria: Medical emergency or any other severe chronic medical condition which makes participation in the study medically inadvisable

Design outcomes

Primary

MeasureTime frame
1. Establish the diagnostic accuracy of the urine antigen ELISA, qPCR, and peripheral blood buffy coat smear microscopy for symptomatic VL in HIV positive patients compared to reference diagnostics. 2. Establish the diagnostic accuracy of the urine antigen ELISA, qPCR, and peripheral blood buffy coat smear microscopy as a test of cure for symptomatic VL in HIV co-infected patients compared to reference diagnostics.Timepoint: Day 0 and day 29.—

Secondary

MeasureTime frame
Establish if test of cure could be conducted at day 15 following initiation of treatment compared to currently used test of cure at day 29. Urine antigen ELISA, qPCR (blood, bone marrow, and skin microbiopsy), and peripheral blood buffy coat smear microscopy will be compared to a bone marrow microbiopsy (parasitological confirmation).Timepoint: Day 15—

Countries

India

Contacts

Public ContactDr Sakib Burza

Médecins Sans Frontières

sakib.burza@barcelona.msf.org

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026