Moxidectin for LF, Cote d'Ivoire (DOLF)

NCT ID: NCT04410406

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2024-09-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Lymphatic Filariasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Recognizing that number and appearance of tablets received in each study arm will be noticeably different, this study will not be completely masked to participants or care providers. To minimize bias, administration of study medications will be performed by a staff member with no role in assessing AEs. AE assessments and all other outcome measures will be assessed by observers masked to the treatment assignment as best as possible.

Study Groups

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IA (Ivermectin + Albendazole)

Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.

Group Type ACTIVE_COMPARATOR

Ivermectin

Intervention Type DRUG

Ivermectin (IVM) 200 µg/kg

Albendazole

Intervention Type DRUG

Albendazole (ABZ) 400 mg

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.

Group Type ACTIVE_COMPARATOR

Albendazole

Intervention Type DRUG

Albendazole (ABZ) 400 mg

Moxidectin

Intervention Type DRUG

Moxidectin (Mox) 8 mg

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.

Group Type ACTIVE_COMPARATOR

Ivermectin

Intervention Type DRUG

Ivermectin (IVM) 200 µg/kg

Diethylcarbamazine

Intervention Type DRUG

Diethylcarbamazine (DEC) 6mg/kg

Albendazole

Intervention Type DRUG

Albendazole (ABZ) 400 mg

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.

Group Type ACTIVE_COMPARATOR

Diethylcarbamazine

Intervention Type DRUG

Diethylcarbamazine (DEC) 6mg/kg

Albendazole

Intervention Type DRUG

Albendazole (ABZ) 400 mg

Moxidectin

Intervention Type DRUG

Moxidectin (Mox) 8 mg

Interventions

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Ivermectin

Ivermectin (IVM) 200 µg/kg

Intervention Type DRUG

Diethylcarbamazine

Diethylcarbamazine (DEC) 6mg/kg

Intervention Type DRUG

Albendazole

Albendazole (ABZ) 400 mg

Intervention Type DRUG

Moxidectin

Moxidectin (Mox) 8 mg

Intervention Type DRUG

Other Intervention Names

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Stromectol Diethylcarbamazine citrate Hetrazan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Case Western Reserve University

OTHER

Sponsor Role collaborator

Regional Hospital of Agboville, Southern Cote d'Ivoire

UNKNOWN

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Budge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Catherine Bjerum, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Toki Pascal Gabo, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Hospital of Agboville, Southern Cote d'Ivoire

Benjamin Koudou, PhD

Role: PRINCIPAL_INVESTIGATOR

Regional Hospital of Agboville, Southern Cote d'Ivoire

Locations

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Regional Hospital of Agboville, Southern Cote d'Ivoire

Agboville, , Côte d’Ivoire

Site Status

Countries

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Côte d’Ivoire

References

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Bjerum CM, Koudou BG, Ouattara AF, Lew D, Goss CW, Gabo PT, King CL, Fischer PU, Weil GJ, Budge PJ. Safety and tolerability of moxidectin and ivermectin combination treatments for lymphatic filariasis in Cote d'Ivoire: A randomized controlled superiority study. PLoS Negl Trop Dis. 2023 Sep 18;17(9):e0011633. doi: 10.1371/journal.pntd.0011633. eCollection 2023 Sep.

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Related Links

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https://tdr.who.int/newsroom/news/item/14-06-2018-first-new-treatment-for-river-blindness-approved-by-u-s-fda-in-20-years

First new treatment for river blindness approved by U.S. FDA in 20 years 2018 \[cited 2018 June 27\].

Other Identifiers

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202005076

Identifier Type: -

Identifier Source: org_study_id

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