ADAPT Phase 2

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201311000659400
• Date of registration: 04/10/2013
• Prospective Registration: Yes
• Primary sponsor: Liverpool School of Tropical Medicine
• Public title: ADAPT Phase 2
• Scientific title: Efficacy and safety of Artemisinin-based Combination Therapies (ACTs) in malaria-infected patients taking Antiretroviral Therapies (ART) in Malawi, Moçambique and Zambia.
• Date of first enrolment: 14/10/2013
• Target sample size: 489
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=659
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Non-randomised
• Phase: Not Applicable

Countries of recruitment

Malawi, Mozambique, Zambia

Contacts

• Name: Victor Mwapasa
• Affiliation: Associate Professor

• Name: Helen Wong
• Affiliation: Administrative Officer

Key inclusion & exclusion 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: 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 < 7 gm/dL.
4. A female patient who is lactating or pregnant at screening.
5. Use any antimalarial treatment and other drugs with antimalarial activity except cotrimoxazole 1 month prior to the screening
6. Known allergy to any of the components or by-products of the ACT which is being used in the clinical trial. This may include artesunate, artemether, artemisinin-derived products, lumefantrine, piperaquine, or amodiaquine.
7. Gastrointestinal dysfunction that could alter absorption or motility (e.g., diarrhoea defined as > 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.


Age minimum: 15 Year(s)
Age maximum: 65 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

HIV/AIDS

Malaria

HIV/AIDS
Malaria

Intervention(s)

Artemether Lumefantrine (AL)

Dihydroartemisinin-piperaquine (DHA/PPQ)

Primary Outcome(s)

malaria parasitemia

Secondary Outcome(s)

gametocytes

piperaquine and lumefantrine concentrations

Hemoglobin concentration

adverse events

Axillary Temperature

Source(s) of Monetary Support

European & Developing Countries Clinical Trials Partnership (EDCTP)

Ethics review

Status: Approved
Approval date: 28/05/2013
Contact:

Liverpool School of Tropical Medicine (LSTM) Ethics Committee

Status: Approved
Approval date: 05/06/2013
Contact:

College of Medicine Research and Ethics Committee (CoMREC)

Status: Approved
Approval date: 30/07/2013
Contact:

Tropical Diseases Research Centre (TDRC) Ethics Review Committee

Status: Not approved
Approval date:
Contact:

Comité Institucional de Bioética para a Saúde