Death to Onchocerciasis and Lymphatic Filariasis (DOLF) Triple Drug Therapy for Lymphatic Filariasis

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The DOLF Triple Drug Therapy for Lymphatic Filariasis study will determine the frequency, type and severity of adverse events following triple-drug therapy (IVM+DEC+ALB, IDA) compared to the standard two-drug treatment (DEC+ALB, DA) in infected and uninfected individuals in a community in 5 different countries. The objective is to acquire safety, efficacy, and acceptability data to assess the safety and acceptability of the IDA drug combination.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: Case Western Reserve University; Indian Council of Medical Research
• Treatments: Albendazole; Diethylcarbamazine; Ivermectin

Criteria

In India:

Inclusion Criteria:

1. Age ≥ 5 years, male or female for IDA arm and age > 2 years for DA arm.

2. Able to provide informed consent to participate in the trial (forms to be attached)

3. No evidence of severe or systemic co-morbidities except for features of filarial disease

Exclusion Criteria:

1. Age < 5 years (ivermectin is contraindicated in children below 5 years of age) for IDA arm and age < 2 years for DA arm

2. Pregnant women (DEC, ivermectin and albendazole are contraindicated in pregnancy)

3. Severe chronic illness (for example, chronic renal failure, inability to care for oneself with activities of daily living)

4. History of previous allergy to MDA drugs

For rest of countries:

Inclusion Criteria:

1. Age ≥ 5 years, for IDA and DA arms (males and females).

2. Able to provide informed consent or give parental consent for minors to participate in the trial

3. No evidence of severe or systemic co-morbidities except for features of filarial disease

Exclusion Criteria:

1. Age < 5 years (ivermectin is not approved for use in children less than 5 years of age)

2. Unable to provide informed consent or give parental consent for minors to participate in the trial

3. Pregnant women (DEC, ivermectin and albendazole are not known to be safe for use during pregnancy)

4. Severe chronic illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living)

5. History of previous allergy to MDA drugs