Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa
Condition: Loiasis
MeSH terms: Loiasis
Intervention: Imatinib Mesylate; Imatinib Mesylate; Imatinib Mesylate; Placebo
Intervention description: A single dose of imatinib 200mg PO is given; A single dose of imatinib 400mg PO is given; A single dose of imatinib 600mg PO is given; A single dose of placebo pill is given
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cameroon; Filaricidal; Randomized; Blinded; Diethylcarbamazine; Imatinib; Loa loa

Summary:

      Background:

      Many people who live in west or central Africa are at risk for infection from a very small
      worm called Loa loa. This infection is acquired through the bite of a fly. Baby worms called
      microfilariae live in the blood. The infection most commonly causes skin itching, mild
      temporary limb swelling, and sometimes a adult worm can be seen in the white of the eye of an
      infected individual. Very rarely, people with this infection can develop problems with the
      kidneys and heart as a result of the worm's effect on the immune system. Because the vast
      majority of people with the infection have minimal symptoms, people in Cameroon usually do
      not get treated. But infection with Loa loa can cause serious problems in people who are
      being treated for infections with other parasites (namely, river blindness and lymphatic
      filariasis). Researchers want to find out of a drug called imatinib can treat Loa loa
      infection so that patients with this infection can safely receive other drugs to cure river
      blindness and lymphatic filariasis. Researchers believe imatinib can be a safe drug to use on
      Loa loa, because in the lab this drug kills the worms slowly, whereas other drugs which can
      cause treatment reactions usually kill the worms very quickly.

      Objective:

      To test if imatinib can treat Loa loa infection by killing the worms slowly.

      Eligibility:

      People ages 18-65 with non-severe Loa loa infection who are otherwise healthy

      Design:

      Participants will be screened with a physical exam and blood and urine tests.

      Participants will have a baseline visit. This will include a physical exam and blood and
      urine tests. It may include a stool sample. Participants will be randomly assigned to get 1
      dose of either imatinib or a placebo.

      Participants will return to the clinic every day for 1 week, then once a week for 3 weeks.
      Visits will include a physical exam and blood tests. They will have urine tests in the first
      week.

      Participants will have follow-up visits 3, 6, and 12 months after taking the imatinib or
      placebo. These include a physical exam and blood tests. They may include urine and stool
      samples.

      If participants develop side effects, they will be treated for them.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. Age greater than or equal to 18 years old and less than or equal to 65 years

               2. Loa loa microfilaremia >500 MF/mL and <2500 MF/mL at screening visit.

               3. Subject has the capacity to understand the potential risks and benefits and
                  consents to protocol indicated blood draws and follow up visits.

        EXCLUSION CRITERIA:

          1. Women under 45 years of age, or over 45 years of age with a menstrual period in the
             preceding 12 months.

          2. Currently breastfeeding

          3. Currently taking daily medications

          4. Known chronic medical conditions, including but not limited to diabetes, renal
             failure, liver disease, seizure disorder, HIV, malignancy, psychiatric disorder, or
             any conditions which within the investigators judgement are deemed to be clinically
             significant.

          5. W. bancrofti serologic positivity against Wb123

          6. O. volvulus serologic positivity against Ov16

          7. HIV by history or clinical signs of HIV/AIDS (e.g. oral thrush, oral/skin lesions of
             Kaposi s sarcoma, etc.)

          8. Any of the following lab abnormalities: Creatinine >1.5, Platelets <100,000/mL,
             Hemoglobin <12g/dL, alanine aminotransferase or aspartate aminotransferase >60 U/L,
             total bilirubin >1.7mg/dL, absolute neutrophil count equal to or less than 1500/mm(3).

          9. Any condition that, in the opinion of the PI, may substantially increase the risk of
             participation, including any contraindication to imatinib.