Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission (ACTIVE)

London School of Hygiene and Tropical Medicine

Status and phase

Completed

Phase 2

Phase 1

Conditions

Malaria

Treatments

Drug: Artemether-lumefantrine combination

Drug: Artemether-lumefantrine combination + repeated dose Ivermectin

Drug: Artemether-lumefantrine combination + single dose Ivermectin

Study type

Interventional

Funder types

Other

Identifiers

NCT01603251

ACTIVE

Details and patient eligibility

About

The purpose of this study is to determine the safety and impact of ivermectin, administered as single or repeated dose, in combination with artemether-lumefantrine in reducing the proportion of mosquitoes that survive and become infected after feeding on a blood meal from a malaria-infected individual.

Enrollment

120 patients

Sex

All

Ages

15 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

asymptomatically infected individuals with any P. falciparum parasite density

Exclusion criteria

age < 15 years or > 25 years
malaria parasite density ≥ 10,000 parasites/µL
clinical symptoms indicating severe malaria
axillary temperature ≥ 37.5°C
Body Mass Index (BMI) below 18 or above 32 kg/m2
haemoglobin concentration below 11 g/dL
taken ivermectin in the last three months
Loa loa as assessed by questionnaire, clinical examination and parasitological assessments
for women: pregnancy or lactation
known hypersensitivity to AL or IVM
history and/or symptoms indicating chronic illness
current use of tuberculosis or anti-retroviral medication
unable to give written informed consent
unwillingness to participate in two membrane feeding assays
travel history to Angola, Cameroon, Chad, Central African Republic, Congo, DR Congo, Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan. If a potential participant has ever visited one or more of these countries, he or she will not be eligible for enrolment.
history of cardiovascular disease.
taking drugs that are known to influence cardiac function and to prolong QTc interval, such as class IA and III: neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes - macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride.
known disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
taking drugs which may be metabolized by cytochrome enzyme CYP2D6 (e.g., flecainide, metoprolol, imipramine, amitriptyline, clomipramine).