A Phase 2 interventional study of Artemether lumefantrine tablets and Artemether Lumefantrine and Imatinib Mesylate in Malaria (Plasmodium Falciparum), sponsored by Victoria Biomedical Research Institute. Recruiting at 1 site in Kenya. Open to participants aged 1 Year to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Victoria Biomedical Research Institute · Phase 2, Interventional, and Treatment
Among 42 studies in Malaria, Falciparum with a site in Kenya — 3 open to participants now, 4 under way, none of them phase 3. Malaria, Falciparum · Kenya.
Among the 42 studies in Malaria, Falciparum with a site in Kenya, this one is the 10th largest by planned enrollment of the 35 interventional ones that give a count, is one of 2 that started in 2026, is one of 14 in phase 2, and was the 40th registered.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
Browse Malaria, Falciparum studies →3 of the 42 studies in Malaria, Falciparum with a site in Kenya are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Kenya, Burkina Faso, Côte D'Ivoire and 4 more countries
Novartis Pharmaceuticals · Sites in Kenya, Burkina Faso, Côte D'Ivoire and 3 more countries
A study can be open while its sites in Kenya have not opened yet or have stopped. Only those recruiting at a site in Kenya →
Of the 21 Malaria, Falciparum studies recruiting now, 5 (24%) set no upper age limit and 15 (71%) stop at 75 or younger; 14 take children under 18; 9 take healthy volunteers.
This study: 1 Year to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 18 · Phase 3 10 · Phase 4 5
First in 2002; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 1,116 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Median enrollment 310 across the 35 interventional studies, 500 across the 7 observational. Of the 37 that completed or were terminated, 15 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 42 have an industry lead sponsor. The 10 most frequent:
Victoria Biomedical Research Institute is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Victoria Biomedical Research Institute has 1 study filed under Malaria, Falciparum — fewer than ten, so there is no comparison to draw.
3 of the studies in Malaria, Falciparum with a site in Kenya that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757167Duke UniversityImproving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics | 2026-12 |
| NCT07811908Novartis PharmaceuticalsPlatform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2) | 2027-02-04 |
| NCT07559370Victoria Biomedical Research InstituteSafety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria | 2027-06-30 |
Among the 42 studies in Malaria, Falciparum with a site in Kenya, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is investigating an innovative approach to treating uncomplicated malaria by adding a drug called Imatinib to the current standard of care, Artemether + Lumefantrine (AL). The researchers hope this combination, known as ALIM, will clear infections faster and stop the spread of drug-resistant parasites that are becoming a major threat in Africa
Most antimalarial drugs work by directly attacking the Plasmodium falciparum parasite, but this approach carries a fundamental weakness: the parasite can slowly rewrite its own biology to shrug off these chemical assaults. Imatinib, a drug already proven safe in cancer treatment for over two decades, takes a radically different tack. Instead of targeting the invader, it targets the human red blood cell that the parasite infects. Specifically, Imatinib inhibits a human enzyme called Syk kinase a key that the parasite turns to pry open the cell and burst forth into the bloodstream. By jamming this lock, the drug traps the parasite inside the cell, where toxic byproducts accumulate and ultimately kill it. Because the parasite cannot alter human biology the way it alters its own, researchers believe resistance to Imatinib will be extraordinarily difficult if not impossible for malaria to evolve.
To test this promising strategy, a clinical trial is now underway at the Alupe sub county hospital in Busia County, Kenya, a region bearing some of the nation's highest malaria burdens. The study unfolds in three cautious phases. First, between ninety and two hundred ten adults will receive varying doses of Imatinib starting at 400 milligrams twice daily to determine the safest regimen. If side effects prove too severe, the dose will be lowered to 600 or 400 milligrams once per day. Once the optimal dose is identified, the second phase will enroll 516 adults to confirm that adding Imatinib to the standard artemether lumefantrine (AL) regimen is as safe as AL alone, and to test whether a two day course works as well as the conventional three days. Finally, because children under five account for nearly eighty percent of malaria deaths, the third phase will extend the trial to younger participants from twelve months to seventeen years using weight based dosing.
Participants who enroll must remain in the hospital for forty eight to seventy two hours of close observation. Medical staff will draw frequent blood samples, often via finger prick, to count parasites and monitor liver and kidney health. After discharge, patients return for follow up visits on days seven, twenty one, and thirty five to ensure the infection has not recurred. To compensate for time and lost wages, each participant receives 1,500 Kenyan shillings per day, and the study covers all travel and medical expenses.
Safety is reinforced by clear boundaries. Although Imatinib is already FDA approved and widely used for cancer, its combination with AL is novel. To avoid dangerous drug interactions, anyone taking medications for high cholesterol, high blood pressure, or HIV cannot enroll. Pregnant or breastfeeding women are also excluded, as Imatinib can harm a developing fetus, and female participants must use birth control throughout the trial.
The study operates under rigorous ethical oversight. It has been reviewed by the Jaramogi Oginga Odinga Teaching and Referral Hospital and the Pharmacy and Poisons Board, while an independent Data Safety Monitoring Board composed of doctors and scientists will continuously review the data to determine whether the trial remains safe to proceed. All participant information is protected under the Kenyan Data Protection Act, ensuring personal privacy is never compromised. Overall, the trial expects to enroll between 906 and 1,116 participants by the end of 2027, with the ultimate goal of delivering a more powerful, resistance proof tool for malaria elimination.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Part 1 and 2 of the study design, all individuals must meet all the inclusion criteria below:
For Part 3 of the trial, all individuals must meet all the inclusion criteria below:
Exclusion Criteria:
Symptoms and signs of severe or complicated malaria including:
Abnormal blood chemistry:
Concomitant use of medicines, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard 3-day course. Used as control in all parts.
Drug: Artemether lumefantrine tablets
3-day course with imatinib 400mg twice daily.
Drug: Artemether Lumefantrine and Imatinib Mesylate
3-day course with optimal dose determined from Part 1.
Drug: Artemether Lumefantrine and Imatinib Mesylate
2-day imatinib course (optimal dose) with 3-day AL.
Drug: Artemether Lumefantrine and Imatinib Mesylate
Weight-based imatinib (340 or 260 mg/m²/day, max 600mg) plus weight-based AL for 3 days.
Drug: Artemether Lumefantrine and Imatinib Mesylate
There is no difference
Drug page: Imatinib
There is no difference
Dose of Imatinib (in mg) Required to Eliminate Viable Parasites
Identification of imatinib dose that eliminates all viable parasites after 2 days of dosing, determined by absence of viable parasites on blood culture from samples taken immediately after 48 hours of study drug administration.
Time frame: 48 hours post-first dose
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity Grade
Safety and tolerability of imatinib mesylate combined with artemether-lumefantrine (AL+IM) compared to artemether-lumefantrine alone (AL). Non-inferior safety defined as insignificant increase (p \> 0.05) in number and severity of adverse events in AL+IM cohorts versus AL alone.
Time frame: Up to Day 35
Number of Participants with PCR-Corrected Recrudescence
Non-inferiority of 2-day AL+IM dosing compared to 3-day AL dosing as determined by PCR-corrected recrudescence using strain genotyping. Non-inferiority defined as insignificant increase (p \> 0.05) in recrudescence in 2-day AL+IM cohorts versus 3-day AL alone.
Time frame: Day 35
Change from Baseline in Parasite Density (parasites/μL)
Accelerated parasite clearance of AL+IM compared to AL alone. Superior efficacy defined as significant decrease (p \< 0.05) in average parasite density in AL+IM cohorts versus AL cohort.
Time frame: Days 1, 2, and 3
Change from Baseline in Body Temperature (°C)
Accelerated decrease in body temperature in AL+IM compared to AL alone. Superior efficacy defined as significant decrease (p \< 0.05) in elevated average body temperature in AL+IM cohorts versus AL cohort.
Time frame: Days 1, 2, and 3
Percentage Reduction in Parasite Density from Baseline
Faster parasite clearance in participants with starting parasite density \>10,000 parasites/μL compared to those with \<10,001 parasites/μL in AL+IM cohorts. Defined as significant decrease (p \< 0.05) in percentage of parasites after first drug administration between high and low baseline density groups.
Time frame: Days 1, 2, and 3
Started Jan 2026 (actual). Primary completion is estimated for Jun 2027, 17 months after the start.
Of 39 phase 2 interventional studies under Malaria, Falciparum, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's planned 17 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Imatinib
Victoria Biomedical Research Institute