Moxidectin for LF, Cote d'Ivoire (DOLF)

• Status: Enrolling by invitation
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Case Western Reserve University; Regional Hospital of Agboville, Southern Cote d'Ivoire
• Treatments: Albendazole; Diethylcarbamazine; Ivermectin; Moxidectin

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