Status:
ACTIVE_NOT_RECRUITING
Moxidectin for LF, Cote d'Ivoire (DOLF)
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Case Western Reserve University
Regional Hospital of Agboville, Southern Cote d'Ivoire
Conditions:
Lymphatic Filariasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04410406
Start Date
August 20 2020
End Date
September 1 2024
Last Update
October 27 2023
Active Locations (1)
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1
Regional Hospital of Agboville, Southern Cote d'Ivoire
Agboville, Côte d’Ivoire