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

NCT ID: NCT01213576

Last Updated: 2015-02-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Lymphatic Filariasis

Keywords

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Lymphatic filariasis microfilaria Albendazole ivermectin human immunodeficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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albendazole 400mg and ivermectin 200mcg/kg

Annual treatment

Group Type ACTIVE_COMPARATOR

Albendazole 400mg and ivermectin 200mcg/kg

Intervention Type DRUG

400 mg orally given annually

Albendazole 400mg and ivermectin 200mcg/kg

Intervention Type DRUG

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

Albendazole 800mg and ivermectin 400mcg/kg

Annual treatment

Group Type ACTIVE_COMPARATOR

Albendazole and ivermectin

Intervention Type DRUG

albendazole 800 mg and ivermectin 400mg orally given annually

Albendazole 400mg and ivermectin 200mcg/kg

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

Group Type ACTIVE_COMPARATOR

Albendazole 400mg and ivermectin 200mcg/kg

Intervention Type DRUG

400 mg orally given annually

Albendazole 400mg and ivermectin 200mcg/kg

Intervention Type DRUG

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

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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Albendazole 400mg and ivermectin 200mcg/kg

400 mg orally given annually

Intervention Type DRUG

Albendazole and ivermectin

albendazole 800 mg and ivermectin 400mg orally given annually

Intervention Type DRUG

Albendazole 400mg and ivermectin 200mcg/kg

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Neil French

Reader In Infectious Disease Epidemiology/Director KPS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neil French, MB ChB PHD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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Karonga Prevention Study

Karonga, , Malawi

Site Status

Countries

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Malawi

References

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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.

Reference Type DERIVED
PMID: 25877874 (View on PubMed)

Other Identifiers

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FED-311207

Identifier Type: -

Identifier Source: org_study_id