Moxidectin for LF, Cote d'Ivoire (DOLF)

January 13, 2026 updated by: Washington University School of Medicine

A Clinical Trial to Assess the Safety and Efficacy of Moxidectin Combination Treatments vs. Ivermectin Combination Treatments for Bancroftian Filariasis

The purpose of this study is to determine whether moxidectin (Mox) will be more effective than ivermectin (IVM) when used in single-dose combination therapies for lymphatic filariasis (LF).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will test the hypothesis that Moxidectin combination therapies are superior to ivermectin combination therapies for achieving sustained clearance of W. bancrofti microfilaremia.

This trial is designed as single-site, Phase III, randomized, open-label, masked-observer superiority trial with four treatment arms: ivermectin + albendazole (IA), moxidectin + albendazole (MoxA), ivermectin + diethylcarbamazine + albendazole (IDA), and moxidectin + diethylcarbamazine + albendazole (MoxDA). The primary endpoint is the proportion of participants achieving complete clearance of microfilaremia at 12 months (IA vs. MoxA comparison) or 24 months (IDA vs. MoxDA comparison). Block randomization by gender will be used to assign treatment arms.

The first 48 participants (12 each arm) will be treated at Agboville Hospital in Cote d'Ivoire at the Centre de Recherche de Filariose with inpatient AE monitoring and collection of post-treatment plasma drug levels (Part 1). For Part 1, active AE surveillance will be conducted in the hospital on days 1, 2, and 3, post-treatment, and in the participant's village of residence on day 7 post-treatment and passive surveillance will be conducted by trained village health workers on days 4-6. An interim safety analysis will take place after Part 1. If no safety concerns are identified, the remainder of the participants will be treated in their home villages, with active AE monitoring on days 1 and 2 post-treatment (Part 2) with passive surveillance by trained village health workers on days 3-7. Any participant in either Part 1 or Part 2 experiencing AEs of grade 2 or higher will be followed until adverse event (AE) severity falls below grade 2. Follow-up assessments for efficacy of treatments for all participants (Parts 1 and 2) will be conducted at 6, 12, 24, and 36 months.

The study includes both safety and efficacy analyses. The safety assessment (Part 1 only) ends 7 days after treatment (unless AEs remain grade 2 or higher). The efficacy assessment (Parts 1 and 2 combined) ends when participants are retested for filarial infection 36 months post-treatment. Participants in the IA arm will receive IA annually (standard of care). Participants in the other arms will receive the assigned treatment at baseline; those found to be microfilaremic at 24 months post-treatment will be retreated with the same treatment received at baseline. If clearance of microfilariae (Mf) at 12 months in the IA arm is superior to Mf clearance in the MoxA arm, the MoxA group will be switched to annual IA treatment.

The study design does not currently include stratification, nor do any sub-studies. However, the study may stratify based on pre-treatment Mf levels if high variability among pre-screening Mf counts is observed.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Côte d’Ivoire
      • Agboville, Côte d’Ivoire
        • Regional Hospital of Agboville, Southern Cote d'Ivoire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Male or female, aged 18-70 years
  • In good general health as evidenced by medical history
  • Peripheral night blood W. bancrofti Mf levels ≥40 Mf/mL
  • No history of taking antifilarial medications in past 12 months
  • Resident of the study area with no plans to change residence in the next 36 months
  • For women of childbearing potential, willing to use appropriate method of contraception for one month following each treatment

Exclusion Criteria:

  • Pregnancy or currently breastfeeding
  • Known allergic reactions to any of the study medications
  • Evidence of severe or systemic comorbidities (aside from features of filarial disease), as judged by the principal investigator
  • Baseline biochemical abnormalities, as indicated by AST, ALT, or creatinine > 2 times the upper limit of normal
  • Evidence of urinary tract infection as indicated by 3+ nitrites on dipstick (individuals with 1+ or 2+ nitrites will not be excluded) or underlying chronic kidney disease as indicated by 3+ protein or 3+ blood on urine dipstick exam
  • Hgb < 7 gm/dL (any such individuals will be referred to the local health center for evaluation and treatment)
  • Positive skin snip for onchocerciasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IA (Ivermectin + Albendazole)
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Drug: Ivermectin
Ivermectin (IVM) 200 µg/kg
Other Names:
  • Stromectol
Drug: Albendazole
Albendazole (ABZ) 400 mg
Active Comparator: MoxA (Moxidectin + Albendazole)
Participants will receive one oral dose of Mox 8 mg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxA at the same dosage.
Drug: Albendazole
Albendazole (ABZ) 400 mg
Drug: Moxidectin
Moxidectin (Mox) 8 mg
Active Comparator: IDA (Ivermectin + Diethylcarbamazine + Albendazole)
Participants will receive one oral dose of IVM 200 µg/kg + Diethylcarbamazine (DEC) 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with IDA at the same dosage.
Drug: Ivermectin
Ivermectin (IVM) 200 µg/kg
Other Names:
  • Stromectol
Drug: Albendazole
Albendazole (ABZ) 400 mg
Drug: Diethylcarbamazine
Diethylcarbamazine (DEC) 6mg/kg
Other Names:
  • Diethylcarbamazine citrate
  • Hetrazan
Active Comparator: MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
Participants will receive one oral dose of Mox 8 mg + DEC 6mg/kg + ABZ 400 mg. Participants who are Mf positive at 24 months will be retreated with MoxDA at the same dosage.
Drug: Albendazole
Albendazole (ABZ) 400 mg
Drug: Moxidectin
Moxidectin (Mox) 8 mg
Drug: Diethylcarbamazine
Diethylcarbamazine (DEC) 6mg/kg
Other Names:
  • Diethylcarbamazine citrate
  • Hetrazan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clearance of Microfilaremia (IA vs. MoxA)
Time Frame: 12 months
The proportion of participants in IA and MoxA study arms with complete clearance of W. bancrofti microfilaremia at 12 months after treatment.
12 months
Clearance of Microfilaremia (IDA vs. MoxDA)
Time Frame: 24 months
The proportion of participants in IDA and MoxDA study arms with complete clearance of W. bancrofti microfilaremia at 24 months after treatment.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clearance of Microfilaremia
Time Frame: 6, 12, 24, & 36 months
The proportion of participants in each study arm with complete clearance of W. bancrofti microfilaremia at 6, 12, 24, & 36 months after treatment.
6, 12, 24, & 36 months
Change in Mf Counts
Time Frame: Assessed at Baseline, 6, 12, & 24 months; Reported at 12 and 24 months
Change in microfilariae counts (relative to baseline) at12 & 24 months
Assessed at Baseline, 6, 12, & 24 months; Reported at 12 and 24 months
Reduction in Circulating Filarial Antigen (CFA) Counts
Time Frame: Assessed at Baseline, 6, 12, & 24 months; 12 and 24 months reported
Reduction in circulating filarial antigen (CFA) counts (relative to baseline) at 12 & 24 months
Assessed at Baseline, 6, 12, & 24 months; 12 and 24 months reported
Inactivation of Adult Worm Nests in Male Participants Only
Time Frame: 6, 12, & 24 months
Inactivation of adult worm nests as assessed by scrotal ultrasound at 6, 12, and 24 months after treatment in male participants only
6, 12, & 24 months
Frequency and Severity of AEs
Time Frame: From baseline treatment to 7 days post-treatment
Frequency and severity of AEs during the first 7 days after treatment.
From baseline treatment to 7 days post-treatment
Plasma Levels of Drugs/Metabolites Post Treatment
Time Frame: Baseline, 2, 3, 4, 6, 12, 24, & 48 hours post-treatment
Noncompartmental pharmacokinetic analyses of DEC, ABZ, ABZSO, ABZSO2, IVM and Mox concentrations will be conducted using WinNonlin (Pharsight Corporation; Cary, North Carolina, USA). Drug plasma concentrations and computed pharmacokinetic parameters will be listed by subject and summarized by drug or metabolite (geometric mean with coefficient of variation, arithmetic mean with standard deviation, minimum, maximum, number of observations). Individual and geometric mean (by time) concentrations versus time will be plotted for each treatment group on both linear and natural logarithm scales.
Baseline, 2, 3, 4, 6, 12, 24, & 48 hours post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Case Western Reserve University
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire

Investigators

  • Principal Investigator: Philip Budge, MD, PhD, Washington University School of Medicine
  • Principal Investigator: Catherine Bjerum, MD, MPH, Case Western Reserve University
  • Principal Investigator: Toki Pascal Gabo, MD, Regional Hospital of Agboville, Southern Cote d'Ivoire
  • Principal Investigator: Benjamin Koudou, PhD, Regional Hospital of Agboville, Southern Cote d'Ivoire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2020

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202005076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified datasets used for published results will be shared publically through a journal or other open source data repository so that the broader scientific community can access it. Datasets used for published results will be shared publically through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared outside of the study team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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