Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa

• Status: Completed
• Trial end date: 2021-03-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Imatinib Mesylate

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.