Post-treatment Effects of Ivermectin (IVM) or Diethylcarbamazine (DEC) in Loiasis
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
Background:
- Loa loa is a small worm that infects people in West and Central Africa. It is spread by
the bite of a fly. Adult worms live under the skin and can cause swelling in the arms,
legs, and face. Some people have more serious infections in the heart, kidneys, or
brain. Most people with Loa loa infection have no symptoms at all. The standard
treatment for Loa loa infection is a medicine called diethylcarbamazine (DEC). Some
people have bad reactions to DEC, including itching, muscle pains, and in severe cases
coma and death.
- Another drug, ivermectin, is used in mass drug treatment programs to prevent the spread
of worm infections that cause blindness and massive swelling (elephantiasis). However,
people who also have Loa loa have had serious bad reactions to ivermectin. Researchers
want to study both DEC and ivermectin to find out why these reactions occur. If they can
be prevented, mass drug treatment programs will be able to be used in areas in Africa
where Loa loa exists.
Objectives:
- To study the side effects of DEC and ivermectin treatment for Loa loa infection.
Eligibility:
- Individuals who live in 4 villages in Cameroon where Loa loa infection is known to exist,
who are between 20 and 60 years of age, not pregnant or breastfeeding and have a low level of
Loa loa parasites in the blood, but are otherwise healthy.
Design:
- Participants will be screened with a physical exam and medical history. Blood samples
will be collected to check for Loa loa infection. Participants will also have an eye
exam and provide skin samples to check for other worm infections that may interfere with
the study treatment.
- Participants will be admitted to the hospital for 4 days (during and after the
treatment). They will receive a single dose of either DEC or ivermectin.
- After treatment, regular blood samples will be collected. Participants will be asked
questions about how they feel after treatment. Physical exams will be performed. If side
effects develop, participants will be treated at the hospital.
- After leaving the hospital, participants will have followup visits. These visits will
happen on days 5, 7, 9, and 14 after receiving the study medicine. They will involve a
short physical exam and collection of blood samples.
- At the end of the study, participants will be offered a full 21-day DEC treatment to
cure the Loa loa infection.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)