Study to evaluate higher doses of liposomal amphotericin B for prevention of relapse in kala-azar patients

Assessment of antirelapse efficacy and safety of high-dose regimens of liposomal amphotericin B in HIV-negative visceral leishmaniasis patients

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/111846

Enrollment

Registered

2026-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: B550- Visceral leishmaniasis

Interventions

Intervention1: Liposomal amphotericin B: Arm B: Single intravenous infusion of liposomal amphotericin B at a dose of 15 milligram per kilogram body weight administered over 4 to 6 hours under medical

Eligibility

Inclusion criteria

Inclusion criteria: -Clinical symptoms of VL -Parasitological confirmation (splenic/Bone Marrow/ PCR) -Written informed consent

Exclusion criteria

Exclusion criteria: HIV positive Coinfections (TB, malaria, HBV, HCV etc.) Severe liver/kidney dysfunction Hypersensitivity to the IP Any other criteria as per the investigator discretion

Design outcomes

Primary

Measure	Time frame
Relapse-free survival up to 24 months after confirmed clinical and parasitological cure at Day 90Timepoint: 24 months after cure achieved at day 90 post-treatment.	—

Secondary

Measure	Time frame
Relapse rate within 2 yearsTimepoint: -Assessed at 24 months (Day 720 14 days) after confirmed clinical and parasitological cure (Day 90) - Interim assessment at 6, 12, and 18 months follow-up visits -Additional assessment at any unscheduled visit in case of suspected relapse ;Safety (Adverse Events, Serious Adverse Events, and laboratory parameter changes)Timepoint: Day 0 7, Day 15, Day 30, Day 90, and 6, 12, 18, 24 months, and throughout study period including unscheduled visits;Parasitological failureTimepoint: Day 30 ( 5 days) and/or Day 90 ( 7 days) post-treatment completion;Clinical failureTimepoint: Defined as persistence of fever beyond 15 days after treatment or worsening clinical condition (e.g., multiorgan involvement) within 7 days post-treatment.	—

Measure

Time frame

Relapse rate within 2 yearsTimepoint: -Assessed at 24 months (Day 720 14 days) after confirmed clinical and parasitological cure (Day 90) - Interim assessment at 6, 12, and 18 months follow-up visits -Additional assessment at any unscheduled visit in case of suspected relapse ;Safety (Adverse Events, Serious Adverse Events, and laboratory parameter changes)Timepoint: Day 0 7, Day 15, Day 30, Day 90, and 6, 12, 18, 24 months, and throughout study period including unscheduled visits;Parasitological failureTimepoint: Day 30 ( 5 days) and/or Day 90 ( 7 days) post-treatment completion;Clinical failureTimepoint: Defined as persistence of fever beyond 15 days after treatment or worsening clinical condition (e.g., multiorgan involvement) within 7 days post-treatment.

—

Countries

India

Contacts

Public ContactDr Krishna Pandey

ICMR- RM NIHR, Patna

pandey.krishna@icmr.gov.in9431042119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026