Post-treatment Effects of Ivermectin (IVM) or Diethylcarbamazine (DEC) in Loiasis
Condition: Loiasis
MeSH terms: Loiasis
Intervention: Diethylcarbamazine; Ivermectin
Intervention description: single dose; single dose
Intervention MeSH terms: Ivermectin; Diethylcarbamazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Loa loa; Immune Response; Therapy

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.
    

Eligibility criteria:

        -  INCLUSION CRITERIA (SCREENING):

        A subject will be eligible for participation in the screening portion of this protocol if
        all of the following criteria apply:

          1. male or non-pregnant and not breastfeeding female subjects,

          2. age 20-60 years (per participant self-report)

          3. resident of Akonolinga

          4. Loa microfilaremia from 20 to 5000 mf/mL from the prior screening in the village or
             did not participate in the prior screening

          5. consent to a blood draw to screen for infection with Loa loa

          6. must be willing to have blood samples stored

        EXCLUSION CRITERIA (SCREENING):

        A subject will not be eligible for participation in the screening portion of this study if
        any of the following conditions apply:

          1. Known to be pregnant (by history) or breastfeeding

          2. Chronic medical conditions, including but not limited to diabetes, renal or hepatic
             insufficiency, immunodeficiency, psychiatric disorder, seizure, that in the
             investigators judgments are deemed to be clinically significant

          3. History of hypersensitivity reaction to DEC or IVM

        INCLUSION CRITERIA (INTERVENTIONAL STUDY):

        A subject will be eligible for participation in the interventional portion of the study
        only if all of the following additional inclusion criteria apply:

          1. Loa loa microfilaremia between 20 and 2,000 mf/mL blood drawn between 11:30 am and
             2:30 pm measured within 30 days prior to the baseline visit

          2. The subject agrees to storage of samples for study

        EXCLUSION CRITERIA (INTERVENTIONAL STUDY):

        A subject will not be eligible to participate in the interventional portion of the study if
        any of the following conditions are fulfilled at the time of enrollment:

          1. Pregnancy (by serum or urine beta-HCG) or breastfeeding

          2. Chronic kidney or liver disease

          3. Hgb < 10 gm/dL

          4. Filarial infection other than Loa loa or M. perstans (O. volvulus, or W. bancrofti)

          5. Use of DEC or IVM within the past 6 months

          6. Use of immunosuppressive therapies, including steroids, within the past month

          7. Any condition that in the investigator s opinion places the subject at undue risk by
             participating in the study

        EXCLUSION OF CHILDREN AND PREGNANT WOMEN:

        Pregnant women and children (the age of consent in Cameroon is 20 years of age) will be
        excluded from this study since it involves administration of medications contraindicated in
        pregnancy and more than minimal risk with no prospect of direct benefit, respectively.