HIV/AIDS Malaria
Conditions
Interventions
Artemether Lumefantrine (AL)
Dihydroartemisinin-piperaquine (DHA/PPQ)
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age ¿15 to ¿65 years old 2. Female patients, if of child-bearing potential must not be pregnant and lactating 3. Body weight > 35 kg 4. Initial parasite densities not exceeding 200,000/µL. 5. Presence of fever (axillary temperature ¿ 37.5 °C or oral ¿ 38 °C) or a history of fever or malaria-like symptoms (nausea, vomiting, myalgia or arthralgia) in the past 24 hours 6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative if a subject is <18 years of age) has been informed of all pertinent aspects of the study and that all questions by the subject have been sufficiently answered. Assent will be obtained from subjects <18 years of age. 7. Willingness and ability to comply with scheduled visits, supervised treatment administration, laboratory tests, and other study procedures. 8. Ability to swallow oral medications.
Exclusion criteria
Exclusion criteria: 1. Patients with severe malaria as per WHO criteria. 2. Patients with mixed infection with another Plasmodium species at the time of presentation (including P. vivax, P. ovale and P. malariae). 3. Hemoglobin (Hb) level of 3 episodes of watery stools in the previous 24 hours or patients who have had 3 episodes of vomiting within 24 hours prior to screening). 8. Participation in any investigational drug trial during the 30 days prior to screening. 9. Evidence of clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, neurological, psychiatric or endocrine diseases or other abnormalities (other than malaria) that may increase the risk associated with study participation 10. Clinical symptoms of febrile conditions due to diseases other than malaria (eg measles, acute respiratory tract infections) that may compromise the evaluation of the response to the study medication. 11. Patients who have had a splenectomy as confirmed by history or clinical examination. 12. Patients with a history of epilepsy or convulsions. 13. Known severe sickle cell (SS) disease or sickle-hemoglobin C (SC) anemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| malaria parasitemia | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events;gametocytes;Axillary Temperature;piperaquine and lumefantrine concentrations;Hemoglobin concentration | — |
Countries
Malawi, Mozambique, Zambia
Contacts
Public ContactHelen Wong
Administrative Officer
Outcome results
None listed