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Lymphatic FilariasisPhase 3NCT04410406

Moxidectin for LF, Cote d'Ivoire (DOLF)

A Phase 3 study testing Ivermectin, Diethylcarbamazine and Albendazole in people with Lymphatic Filariasis, run by Washington University School of Medicine at 1 site in Côte d’Ivoire.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Lymphatic Filariasis
What is being tested?
Ivermectin, Diethylcarbamazine and Albendazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
1 siteCôte d’Ivoire
Study dates
20 Aug 2020to 1 Oct 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Côte d’Ivoire1 site

  • Regional Hospital of Agboville, Southern Cote d'Ivoire

    Agboville

Other trials in Côte d’Ivoire

About this study

Official title: 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).

Read the 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.

Being tested
Ivermectin, Diethylcarbamazine, Albendazole, Moxidectin
Keywords
moxidectin, ivermectin
Medical subject headings
Elephantiasis, Filarial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvermectinDrug

    Also called Stromectol

    Ivermectin (IVM) 200 µg/kg

  • DiethylcarbamazineDrug

    Also called Diethylcarbamazine citrate, Hetrazan

    Diethylcarbamazine (DEC) 6mg/kg

  • AlbendazoleDrug

    Albendazole (ABZ) 400 mg

  • MoxidectinDrug

    Moxidectin (Mox) 8 mg

Study groups in NCT04410406
Study groupRoleWhat they receive
IA (Ivermectin + Albendazole)Active comparatorParticipants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Receives: Drug: Ivermectin; Drug: Albendazole
MoxA (Moxidectin + Albendazole)Active comparatorParticipants 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.
Receives: Drug: Albendazole; Drug: Moxidectin
IDA (Ivermectin + Diethylcarbamazine + Albendazole)Active comparatorParticipants 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.
Receives: Drug: Ivermectin; Drug: Diethylcarbamazine; Drug: Albendazole
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)Active comparatorParticipants 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.
Receives: Drug: Diethylcarbamazine; Drug: Albendazole; Drug: Moxidectin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clearance of Microfilaremia (IA vs. MoxA)

    The proportion of participants in IA and MoxA study arms with complete clearance of W. bancrofti microfilaremia at 12 months after treatment.

    Measured: 12 months

  2. Clearance of Microfilaremia (IDA vs. MoxDA)

    The proportion of participants in IDA and MoxDA study arms with complete clearance of W. bancrofti microfilaremia at 24 months after treatment.

    Measured: 24 months

Secondary outcomes (6)

  1. Clearance of Microfilaremia

    The proportion of participants in each study arm with complete clearance of W. bancrofti microfilaremia at 6, 12, 24, \& 36 months after treatment.

    Measured: 6, 12, 24, & 36 months

  2. Change in Mf Counts

    Change in microfilariae counts (relative to baseline) at12 \& 24 months

    Measured: Assessed at Baseline, 6, 12, & 24 months; Reported at 12 and 24 months

  3. Reduction in Circulating Filarial Antigen (CFA) Counts

    Reduction in circulating filarial antigen (CFA) counts (relative to baseline) at 12 \& 24 months

    Measured: Assessed at Baseline, 6, 12, & 24 months; 12 and 24 months reported

  4. Inactivation of Adult Worm Nests in Male Participants Only

    Inactivation of adult worm nests as assessed by scrotal ultrasound at 6, 12, and 24 months after treatment in male participants only

    Measured: 6, 12, & 24 months

  5. Frequency and Severity of AEs

    Frequency and severity of AEs during the first 7 days after treatment.

    Measured: From baseline treatment to 7 days post-treatment

  6. Plasma Levels of Drugs/Metabolites 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.

    Measured: Baseline, 2, 3, 4, 6, 12, 24, & 48 hours post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start20 Aug 2020
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This trial is a single-site, Phase III, randomized, open-label, masked-observer superiority trial with four treatment arms (IA, MoxA, IDA, and MoxDA). Block randomization by gender will be used to assign treatment arms.
Masking
None (open label)
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04410406
Sponsor's protocol ID
202005076
Status last verified
Jan 2026
First submitted
27 May 2020
Last updated
29 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Opoku NO, Bakajika DK, Kanza EM, Howard H, Mambandu GL, Nyathirombo A, Nigo MM, Kasonia K, Masembe SL, Mumbere M, Kataliko K, Larbelee JP, Kpawor M, Bolay KM, Bolay F, Asare S, Attah SK, Olipoh G, Vaillant M, Halleux CM, Kuesel AC. Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double-blind phase 3 trial. Lancet. 2018 Oct 6;392(10154):1207-1216. doi: 10.1016/S0140-6736(17)32844-1. Epub 2018 Jan 18.

    PubMed 29361335

  • Ichimori K, King JD, Engels D, Yajima A, Mikhailov A, Lammie P, Ottesen EA. Global programme to eliminate lymphatic filariasis: the processes underlying programme success. PLoS Negl Trop Dis. 2014 Dec 11;8(12):e3328. doi: 10.1371/journal.pntd.0003328. eCollection 2014 Dec. No abstract available.

    PubMed 25502758

  • Ottesen EA, Duke BO, Karam M, Behbehani K. Strategies and tools for the control/elimination of lymphatic filariasis. Bull World Health Organ. 1997;75(6):491-503.

    PubMed 9509621

  • Ottesen EA. Lymphatic filariasis: Treatment, control and elimination. Adv Parasitol. 2006;61:395-441. doi: 10.1016/S0065-308X(05)61010-X.

    PubMed 16735170

  • Thomsen EK, Sanuku N, Baea M, Satofan S, Maki E, Lombore B, Schmidt MS, Siba PM, Weil GJ, Kazura JW, Fleckenstein LL, King CL. Efficacy, Safety, and Pharmacokinetics of Coadministered Diethylcarbamazine, Albendazole, and Ivermectin for Treatment of Bancroftian Filariasis. Clin Infect Dis. 2016 Feb 1;62(3):334-341. doi: 10.1093/cid/civ882. Epub 2015 Oct 20.

    PubMed 26486704

  • King CL, Suamani J, Sanuku N, Cheng YC, Satofan S, Mancuso B, Goss CW, Robinson LJ, Siba PM, Weil GJ, Kazura JW. A Trial of a Triple-Drug Treatment for Lymphatic Filariasis. N Engl J Med. 2018 Nov 8;379(19):1801-1810. doi: 10.1056/NEJMoa1706854.

    PubMed 30403937

  • Edi C, Bjerum CM, Ouattara AF, Chhonker YS, Penali LK, Meite A, Koudou BG, Weil GJ, King CL, Murry DJ. Pharmacokinetics, safety, and efficacy of a single co-administered dose of diethylcarbamazine, albendazole and ivermectin in adults with and without Wuchereria bancrofti infection in Cote d'Ivoire. PLoS Negl Trop Dis. 2019 May 20;13(5):e0007325. doi: 10.1371/journal.pntd.0007325. eCollection 2019 May.

    PubMed 31107869

  • Irvine MA, Stolk WA, Smith ME, Subramanian S, Singh BK, Weil GJ, Michael E, Hollingsworth TD. Effectiveness of a triple-drug regimen for global elimination of lymphatic filariasis: a modelling study. Lancet Infect Dis. 2017 Apr;17(4):451-458. doi: 10.1016/S1473-3099(16)30467-4. Epub 2016 Dec 22.

    PubMed 28012943

  • Kyelem D, Biswas G, Bockarie MJ, Bradley MH, El-Setouhy M, Fischer PU, Henderson RH, Kazura JW, Lammie PJ, Njenga SM, Ottesen EA, Ramaiah KD, Richards FO, Weil GJ, Williams SA. Determinants of success in national programs to eliminate lymphatic filariasis: a perspective identifying essential elements and research needs. Am J Trop Med Hyg. 2008 Oct;79(4):480-4.

    PubMed 18840733

  • Molyneux DH, Hopkins A, Bradley MH, Kelly-Hope LA. Multidimensional complexities of filariasis control in an era of large-scale mass drug administration programmes: a can of worms. Parasit Vectors. 2014 Aug 15;7:363. doi: 10.1186/1756-3305-7-363.

    PubMed 25128408

  • Horton J. Albendazole: a broad spectrum anthelminthic for treatment of individuals and populations. Curr Opin Infect Dis. 2002 Dec;15(6):599-608. doi: 10.1097/00001432-200212000-00008.

    PubMed 12821837

  • Horton J, Witt C, Ottesen EA, Lazdins JK, Addiss DG, Awadzi K, Beach MJ, Belizario VY, Dunyo SK, Espinel M, Gyapong JO, Hossain M, Ismail MM, Jayakody RL, Lammie PJ, Makunde W, Richard-Lenoble D, Selve B, Shenoy RK, Simonsen PE, Wamae CN, Weerasooriya MV. An analysis of the safety of the single dose, two drug regimens used in programmes to eliminate lymphatic filariasis. Parasitology. 2000;121 Suppl:S147-60. doi: 10.1017/s0031182000007423.

    PubMed 11386686

  • Kitzman D, Cheng KJ, Fleckenstein L. HPLC assay for albendazole and metabolites in human plasma for clinical pharmacokinetic studies. J Pharm Biomed Anal. 2002 Oct 15;30(3):801-13. doi: 10.1016/s0731-7085(02)00382-5.

    PubMed 12367706

  • Geary TG. Ivermectin 20 years on: maturation of a wonder drug. Trends Parasitol. 2005 Nov;21(11):530-2. doi: 10.1016/j.pt.2005.08.014. Epub 2005 Aug 26.

    PubMed 16126457

  • Moreno Y, Nabhan JF, Solomon J, Mackenzie CD, Geary TG. Ivermectin disrupts the function of the excretory-secretory apparatus in microfilariae of Brugia malayi. Proc Natl Acad Sci U S A. 2010 Nov 16;107(46):20120-5. doi: 10.1073/pnas.1011983107. Epub 2010 Nov 1.

    PubMed 21041637

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ivermectin, Diethylcarbamazine and Albendazole in people with Lymphatic Filariasis, run by Washington University School of Medicine at 1 site in Côte d’Ivoire.

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 7 inclusion and 7 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: finished, as of the sponsor's last update on 29 Jan 2026. 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 Côte d’Ivoire. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clearance of Microfilaremia (IA vs. MoxA) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04410406, which also lists 30 linked publications.

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 29 Jan 2026.

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