Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi
Information source: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphatic Filariasis
Intervention: Albendazole 400mg and ivermectin 200mcg/kg (Drug); Albendazole and ivermectin (Drug); Albendazole 400mg and ivermectin 200mcg/kg (Drug); albendazole 800mg and ivermectin 400mcg/kg bi-annually (Drug)
Phase: N/A
Status: Terminated
Sponsored by: London School of Hygiene and Tropical Medicine Official(s) and/or principal investigator(s):
Neil French, MB ChB PHD, Principal Investigator, Affiliation: London School of Hygiene and Tropical Medicine
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.
Clinical Details
Official title: Efficacy of Higher Albendazole and Ivermectin Doses on Wuchereria Bancrofti Microfilarial Clearance in Malawi, Open Label Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants Achieving Microfilarial Clearance
Secondary outcome: Number of Participants With Microfilarial Clearance at 24 Months of Follow up
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Karonga Prevention Study, Karonga, Malawi
Additional Information
Task Force for Child survival
Starting date: January 2009
Last updated: February 26, 2015
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