Lymphatic Filariasis (LF) in Ivory Coast

• Status: Completed
• Trial end date: 2018-09-25
• Target enrollment: 0
• Participant gender: All

Summary

The recommended treatment for elimination of LF in sub-Saharan Africa is annual mass drug administration (MDA) with single dose Albendazole (ALB) plus Ivermectin (IVM) given for at least 5-7 years. However, in areas where LF is co-endemic with a related filarial parasite, Loa loa, co-infection with L. loa represents a serious barrier to LF elimination because IVM used in LF MDA can result in severe reactions and even death in individuals with high microfilaria (mf) levels of L. loa. Screening for heavy L. loa infection is problematic. To overcome this problem, monotherapy with ALB is possible, since this drug has little or no effect on circulating mf and thus would not cause adverse effects in people with heavy L. loa infections. Moreover ALB has been shown to have embryostatic or embryocidal effects in female adult worms resulting in decreased mf levels with time as natural attrition of circulating mf occurs. Thus this open-label, randomized clinical trial will examine treatment with ALB monotherapy administered twice per year over a period of 3 years with the primary endpoint being the proportion of individuals with total clearance of mf at 36 months and Alere antigen test negativity (a more sensitive circulating antigen test of filarial infection). Two of the treatment arms will include ALB at two different doses, 400mg or 800mg (fixed dose twice yearly) as compared to standard treatment of ALB (400 mg) plus IVM (150-200 µg/kg) administered annually. Observations from an ongoing clinical trial in Papua New Guinea suggest that a single dose of triple therapy with ALB + IVM + DEC may be highly effective in sterilizing adult female worms. Therefore to confirm and expand these important preliminary observations in a different population, a fourth arm will be included in the current clinical trial in which subjects will receive all three drugs. The clinical trial will be performed in a region of Cote d'Ivoire where onchocerciasis and loiasis are not endemic.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: Washington University School of Medicine
• Treatments: Albendazole; Diethylcarbamazine; Ivermectin

Criteria

Inclusion Criteria:

• Women and men 18-70 years

• ≥50 MF/mL based on Nuclepore filtration

• Willing to give informed consent

Exclusion Criteria:

• Prior treatment for LF within last 5 years

• Pregnancy (perform pregnancy test)

• Hemoglobin <7 g/dL

• Permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension

• AST/ALT and creatinine >1.5 upper limit of normal

• Proteinuria or hematuria >3+

• Skin snip positivity for O. volvulus MF