Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa
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|ClinicalTrials.gov Identifier: NCT02644525|
Recruitment Status : Active, not recruiting
First Posted : January 1, 2016
Last Update Posted : September 21, 2020
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.
To test if imatinib can treat Loa loa infection by killing the worms slowly.
People ages 18-65 with non-severe Loa loa infection who are otherwise healthy
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.
|Condition or disease||Intervention/treatment||Phase|
|Loaisis||Drug: Imatinib Mesylate Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blinded, Randomized, Placebo-Controlled Dose Escalation Study to Examine the Microfilaricidal Kinetics and Safety of Imatinib for the Treatment of Loa Loa (A Pilot Study)|
|Actual Study Start Date :||September 16, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Placebo Comparator: 2
Subjects given vitamin placebo
Subjects given drug (200 mg, 400 mg, or 600 mg)
Drug: Imatinib Mesylate
Imatinib is a small molecule inhibitor which was US Food and Drug Administration (FDA) -approved for chronic myelogenous leukemia (CML) in 2001 which acts on the protein product of the Philadelphia chromosome, Bcr-Abl.
- To determine the short-term microfilaricidal kinetics of imatinib against Loa loa. [ Time Frame: 4 days ]Percent of baseline Loa loa microfilariae at day 4 as determined by concentrated peripheral blood smear
- To assess the safety of a single dose of imatinib in Loa loa infection [ Time Frame: To determine the efficacy of single dose imatinib as a microfilaricide at 1-, 3-, 6-, and 12-month time points. ]Tables of adverse events by treatment group including grades of AEs, as defined by CTCAE (Common Terminology Criteria for AdverseEvents v4.0).Percent of baseline Loa loa microfilariae over time (up to 12 months).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644525
|Centre de Recherche sur les Filarioses et Autres Maladies Tropicales|
|Principal Investigator:||Elise M O'Connell, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|