Phase 3
N=164
Moxidectin for LF, Cote d'Ivoire (DOLF)
Lymphatic Filariasis
Bottom Line
View on ClinicalTrials.gov: NCT04410406 ↗Enrolled (actual)
164
Serious AEs
2.4%
Results posted
Jan 2026
Primary outcome: Primary: Clearance of Microfilaremia (IA vs. MoxA) — 8; 18; 24; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ivermectin (Drug); Diethylcarbamazine (Drug); Albendazole (Drug); Moxidectin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clearance of Microfilaremia (IA vs. MoxA) |
8; 18; 24; 27 | — |
| PRIMARY Clearance of Microfilaremia (IDA vs. MoxDA) |
13; 14; 20; 21 | — |
| SECONDARY Clearance of Microfilaremia |
8; 15; 20; 24; 8; 18 | — |
| SECONDARY Change in Mf Counts |
20.70; 0.48; 1.30; 0.05; 8.10; 2.50 | — |
| SECONDARY Reduction in Circulating Filarial Antigen (CFA) Counts |
21.70; 12.50; 10.30; 7.80; 12.16; 6.38 | — |
| SECONDARY Inactivation of Adult Worm Nests in Male Participants Only |
1; 7; 10; 10; 4; 8 | — |
| SECONDARY Frequency and Severity of AEs |
22; 24; 18; 15 | — |
| SECONDARY Plasma Levels of Drugs/Metabolites Post Treatment |
116.2; 172.1; 124.2; 82.4; 3302.3; 4078.9 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT04410406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.