Overview

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