Clinical trial NCT01213576: Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi
Official title: Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi, Open Label Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lymphatic Filariasis
Keywords: Lymphatic filariasis
microfilaria
Albendazole
ivermectin
human immunodeficiency
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2010-10-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such programmes is very high and has proven to be a major impediment to the success of programmes in many countries with limited financial resources.

Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. It is essential to determine whether such higher doses are indeed beneficial since this could have far-reaching effects on the conduct and management of the main mass treatment programmes and also in the management of programmes as they near elimination.

Detailed description: The proposed study will enrol up to 120 volunteers with microfilaremic Wuchereria bancrofti infection who would be randomized to receive standard annual treatment (albendazole 400 mg + ivermectin 200 mcg/kg), annual treatment with an increased dose of albendazole (albendazole 800 mg + ivermectin 200400 mcg/kg) or semi-annual treatment with a standard (albendazole 400 mg + ivermectin 200 mcg/kg), or an increased albendazole dose (albendazole 800 mg + ivermectin 200 400 mcg/kg). Microfilarial levels, as well as measures of adult worm burden (circulating antigen) will be followed every six months for two years to determine whether the higher doses, or more frequent regimens are more effective.

The data obtained would be used, in combination with the data from other similar studies being conducted in Mali and in India to advise the Global Programme for the Elimination of Lymphatic Filariasis (GPELF) on improved methods of treatment both for mass treatment and for the management of problem areas within the global programme.

Eligibility criteria: Inclusion Criteria:

* understand and sign informed consent
* willing to undergo night blood sampling every 6 months for 2 years
* Age 18 to 55 years
* Haemoglobin of equal or above 9g/dl
* Microfilarial level of equal or above 80mg/dl

Exclusion Criteria:

* Non- consenting
* Pregnancy or lactation
* Treatment with albendazole or ivermectin within the previous 6 months
* Known allergy to the study drugs

Primary outcomes:
measure: Number of Participants Achieving Microfilarial Clearance
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Microfilarial Clearance at 24 Months of Follow up
timeFrame: 24 months
Other outcomes:
Locations:
city: Karonga
country: Malawi
facility: Karonga Prevention Study
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Neil French, MB ChB PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tafatatha TT, Ngwira BM, Taegtmeyer M, Phiri AJ, Wilson TP, Banda LG, Piston WN, Koole O, Horton J, French N. Randomised controlled clinical trial of increased dose and frequency of albendazole and ivermectin on Wuchereria bancrofti microfilarial clearance in northern Malawi. Trans R Soc Trop Med Hyg. 2015 Jun;109(6):393-9. doi: 10.1093/trstmh/trv027. Epub 2015 Apr 15.