Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi (FED)

London School of Hygiene and Tropical Medicine

Status: Terminated

Conditions: Lymphatic Filariasis

Treatments: Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually; Drug: Albendazole and ivermectin; Drug: Albendazole 400mg and ivermectin 200mcg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT01213576

FED-311207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 4 patient groups

albendazole 400mg and ivermectin 200mcg/kg

Active Comparator group

Description:

Annual treatment

Treatment:

Drug: Albendazole 400mg and ivermectin 200mcg/kg

Drug: Albendazole 400mg and ivermectin 200mcg/kg

Albendazole 800mg and ivermectin 400mcg/kg

Active Comparator group

Description:

Annual treatment

Treatment:

Drug: Albendazole and ivermectin

Albendazole 400mg and ivermectin 200mcg/kg

Active Comparator group

Description:

albendazole 400mg and ivermectin 200mcg/kg given twice a year

Treatment:

Drug: Albendazole 400mg and ivermectin 200mcg/kg

Drug: Albendazole 400mg and ivermectin 200mcg/kg

Albendazole 800mg and ivermectin 400mcg /kg bi-annually

Active Comparator group

Description:

Albendazole 800mg and ivermectin 400mcg/kg given twice a year

Treatment:

Drug: albendazole 800mg and ivermectin 400mcg/kg bi-annually