Ivermectin Repurposed for the Treatment of PKDL

NCT07286604 | Completed Early Phase 1 DMC

• 1 other identifier: PR-21134
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Background (brief):

1. 1.Burden: Post-Kala-Azar Dermal Leishmaniasis (PKDL) commonly follows visceral leishmaniasis (VL) caused by Leishmania donovani. It is characterized by skin lesions in which parasites can be identified, in a patient who is otherwise fully recovered from VL or exposed to L. donovani (LD) infection. It occurs in the Indian subcontinent (mainly India and Bangladesh) as well as in Africa (mainly Sudan). It is now established that PKDL patients play an important role in transmission of LD parasite where chronic PKDL patients have been implicated in major VL outbreaks in the past. In a series of cross-sectional surveys between 2002-2010, the cumulative incidence of PKDL was estimated at 17% by 5 years in Bangladesh. Most patients had been treated with SSG (95%); the mean interval between VL and PKDL was 19 months. A recent longitudinal study in Fulbaria (2015) of 1918 VL patients with active follow-up showed PKDL rates of 10.2% at 36 months (mean 17.6 months; range 4-43 months) after VL treated with 6 x 5 mg/kg Ambisome® (Koert Ritmeijer, MSF, personal communication). Though VL cases are in decline due to extensive programmes conducted by NKEP, PKDL cases are in the rise and VL:PKDL ratio has risen from 1:0.47 to 1:1.21 from 2016 to 2020. In this current situation, elimination of PKDL cases is of crucial importance in the current VL elimination efforts in Bangladesh as well as in the Indian subcontinent.
2. 2.Knowledge gap: Currently there are no satisfactory treatments for any forms of PKDL. Available treatments include pentavalent antimonial sodium stibogluconate (Pentostam, Stibonate) which have been used since the 1940s. Conventional amphotericin B has been used in India for prolonged periods (60 infusions) but this is impractical and requires careful clinical and biochemical monitoring. Both miltefosine and Ambisome® as monotherapy have shown to be effective. However, with the current recommended scheme there are some drawbacks such as the length of the treatment with miltefosine alone (8-12 weeks), toxicity related to it; a high dose Ambisome® (total dose of 20 mg/kg) given frequently in 4 divided dosage often causes adverse events (e.g. pancytopania, hypokalemia, increased creatinine level etc.). There is also the potential risk for development of resistance with miltefosine as monotherapy. Ivermectin has been proven to have a significant leishmanicidal effect by several experimental studies at higher doses without significant toxicity and may offer shorter duration of treatment thus preventing prolonged hospitalization.
3. 3.Relevance: This study aims primarily to improve current treatment options. In addition, this will be the first human study ever in PKDL in relation to Ivermectin, in which outcome will be described in clinical, parasitological and immunological terms. Ultimately this study findings will help National Kala-Azar Elimination Program (NKAEP) to adopt specific strategies for elimination of PKDL cases.

Conditions

Post Kala Azar Dermal Leishmaniasis

Outcome Measures

Primary Outcomes (2)

• Number of Severe Adverse Events in Participants

  Zero Severe Adverse Events recorded in any of the patients treated with Ivermectin

  Within 3 months following enrollment

• Number of Participants with Negative PCR Results

  PCR in Skin samples will be negative for LD-bodies in all the Ivermectin-treated patients

  Within 12 months after treatment completion

Secondary Outcomes (1)

• Rate of Reduction in Lesion Number

  Within 12 months after treatment completion

Study Arms (1)

Tablet Ivermectin

EXPERIMENTAL

Drug: Ivermectin 6 MG Oral Tablet (2 tablets)

Interventions

Ivermectin 6 MG Oral Tablet (2 tablets) DRUG

A cumulative dose of 60 mg Oral Ivermectin monotherapy (12 mg/day) on five consecutive days (day 1 - day 5) for three consecutive months (180 mg in total)

Tablet Ivermectin

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed PKDL case of either sex aged more than 5 years,
• Clinically healthy except skin lesions,
• Free from chronic illness
• Normal serum glucose, creatinine and SGPT, Hb ≥ 10 g/dL (male) and 8 g/dL (Female)
• Voluntary participation through informed voluntary written consent.

You may not qualify if:

• Patients who received VL or PKDL treatment within 12 months
• Pregnant / lactating women

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Interventions

Ivermectin; Tablets

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Shomik Maruf

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: March 2, 2022
• Primary Completion: June 25, 2022
• Study Completion: June 6, 2023
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)