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Moxidectin for LF, Cote d'Ivoire (DOLF)

Primary Purpose

Lymphatic Filariasis

Status
Active
Phase
Phase 3
Locations
Côte D'Ivoire
Study Type
Interventional
Intervention
Ivermectin
Diethylcarbamazine
Albendazole
Moxidectin
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphatic Filariasis focused on measuring moxidectin, ivermectin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Regional Hospital of Agboville, Southern Cote d'Ivoire

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

IA (Ivermectin + Albendazole)

MoxA (Moxidectin + Albendazole)

IDA (Ivermectin + Diethylcarbamazine + Albendazole)

MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Reduction in Mf counts
Reduction in microfilariae counts (relative to baseline) at 6, 12, & 24 months
Reduction in circulating filarial antigen (CFA) counts
Reduction in circulating filarial antigen (CFA) counts (relative to baseline) at 6, 12, & 24 months
Inactivation of adult worm nests
Inactivation of adult worm nests as assessed by scrotal ultrasound at 6, 12, and 24 months after treatment
Frequency and severity of AEs
Frequency and severity of AEs during the first 7 days after treatment.
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.

Full Information

First Posted
May 27, 2020
Last Updated
October 3, 2022
Sponsor
Washington University School of Medicine
Collaborators
Case Western Reserve University, Regional Hospital of Agboville, Southern Cote d'Ivoire
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1. Study Identification

Unique Protocol Identification Number
NCT04410406
Brief Title
Moxidectin for LF, Cote d'Ivoire (DOLF)
Official Title
A Clinical Trial to Assess the Safety and Efficacy of Moxidectin Combination Treatments vs. Ivermectin Combination Treatments for Bancroftian Filariasis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Case Western Reserve University, Regional Hospital of Agboville, Southern Cote d'Ivoire

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Filariasis
Keywords
moxidectin, ivermectin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Masking Description
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.
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IA (Ivermectin + Albendazole)
Arm Type
Active Comparator
Arm Description
Participants will receive one oral dose of Ivermectin (IVM) 200 µg/kg + Albendazole (ABZ) 400 mg (IA) annually for 24 months.
Arm Title
MoxA (Moxidectin + Albendazole)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IDA (Ivermectin + Diethylcarbamazine + Albendazole)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MoxDA (Moxidectin + Diethylcarbamazine + Albendazole)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
Stromectol
Intervention Description
Ivermectin (IVM) 200 µg/kg
Intervention Type
Drug
Intervention Name(s)
Diethylcarbamazine
Other Intervention Name(s)
Diethylcarbamazine citrate, Hetrazan
Intervention Description
Diethylcarbamazine (DEC) 6mg/kg
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Description
Albendazole (ABZ) 400 mg
Intervention Type
Drug
Intervention Name(s)
Moxidectin
Intervention Description
Moxidectin (Mox) 8 mg
Primary Outcome Measure Information:
Title
Clearance of microfilaremia (IA vs. MoxA)
Description
The proportion of participants in IA and MoxA study arms with complete clearance of W. bancrofti microfilaremia at 12 months after treatment.
Time Frame
12 months
Title
Clearance of microfilaremia (IDA vs. MoxDA)
Description
The proportion of participants in IDA and MoxDA study arms with complete clearance of W. bancrofti microfilaremia at 24 months after treatment.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Clearance of microfilaremia
Description
The proportion of participants in each study arm with complete clearance of W. bancrofti microfilaremia at 6, 12, 24, & 36 months after treatment.
Time Frame
6, 12, 24, & 36 months
Title
Reduction in Mf counts
Description
Reduction in microfilariae counts (relative to baseline) at 6, 12, & 24 months
Time Frame
Baseline, 6, 12, & 24 months
Title
Reduction in circulating filarial antigen (CFA) counts
Description
Reduction in circulating filarial antigen (CFA) counts (relative to baseline) at 6, 12, & 24 months
Time Frame
Baseline, 6, 12, & 24 months
Title
Inactivation of adult worm nests
Description
Inactivation of adult worm nests as assessed by scrotal ultrasound at 6, 12, and 24 months after treatment
Time Frame
6, 12, & 24 months
Title
Frequency and severity of AEs
Description
Frequency and severity of AEs during the first 7 days after treatment.
Time Frame
From baseline treatment to 7 days post-treatment
Title
Plasma levels of drugs/metabolites post treatment
Description
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.
Time Frame
Baseline, 2, 3, 4, 6, 12, 24, & 48 hours post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Budge, MD, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Bjerum, MD, MPH
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Toki Pascal Gabo, MD
Organizational Affiliation
Regional Hospital of Agboville, Southern Cote d'Ivoire
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin Koudou, PhD
Organizational Affiliation
Regional Hospital of Agboville, Southern Cote d'Ivoire
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Hospital of Agboville, Southern Cote d'Ivoire
City
Agboville
Country
Côte D'Ivoire

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Links:
URL
https://tdr.who.int/newsroom/news/item/14-06-2018-first-new-treatment-for-river-blindness-approved-by-u-s-fda-in-20-years
Description
First new treatment for river blindness approved by U.S. FDA in 20 years 2018 [cited 2018 June 27].

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Moxidectin for LF, Cote d'Ivoire (DOLF)

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