Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201311000659400 Date of Approval: 04/10/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ADAPT Phase 2
Official scientific title Efficacy and safety of Artemisinin-based Combination Therapies (ACTs) in malaria-infected patients taking Antiretroviral Therapies (ART) in Malawi, Moçambique and Zambia.
Brief summary describing the background and objectives of the trial Artemisin-based combination therapies (ACTs) are metabolized by liver enzymes which are induced or inhibited by antiretroviral (ARV) drugs such as efavirenz (EFV) and nevirapine (NVP). This clinical trial aims at assessing the efficacy and safety artemether-lumefantrine (AL) and dihydroartemisin-piperaquine (DHA-PPQ) in people with uncomplicated plasmodium falciparum malaria taking NVP or EFV-based Antiretroviral Therapy (ART).
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ADAPT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS,Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 14/10/2013
Actual trial start date 23/10/2013
Anticipated date of last follow up 30/09/2014
Actual Last follow-up date 30/06/2015
Anticipated target sample size (number of participants) 489
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Artemether Lumefantrine (AL) AL 20mg/120mg, 4 tabs, twice daily 3 days Antimalarial drug, AL used in people taking 3TC-TDF-EFV 163
Experimental Group Dihydroartemisinin-piperaquine (DHA/PPQ) DHA/PPQ 40mg/320mg, 3-4 tablets, once daily 3 days Antimalarial drug DHA/PPQ in people taking 3TC-TDF-EFV 163
Experimental Group Dihydroartemisinin-piperaquine (DHA/PPQ) DHA/PPQ 40mg/320mg, 3-4 tablets, once daily 3 days Antimalarial drug DHA/PPQ in people taking 3TC-d4T-NVP or 3TC-AZT-NVP 163
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. 15 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/06/2013 College of Medicine Research and Ethics Committee (CoMREC)
Ethics Committee Address
Street address City Postal code Country
1 Mahatma Gandhi Road Blantyre
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/05/2013 Liverpool School of Tropical Medicine (LSTM) Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Pembroke Place Liverpool L3 5QA United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/07/2013 Tropical Diseases Research Centre (TDRC) Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Ndola Central Hospital Building, Corner of Nkana and Broadway Roads Ndola Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 23/09/2013 Comité Institucional de Bioética para a Saúde
Ethics Committee Address
Street address City Postal code Country
Rua 12, Cambeve, Vila da Manhiça Manhiça CP 1929 Mozambique
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome malaria parasitemia Day 0 Day 1 Day 2 Day 3 Day 7 Day 14 Day 21 Day 28 Day 35 Day 42
Secondary Outcome adverse events day 0 to day 63
Secondary Outcome gametocytes day 0 to day 63
Secondary Outcome Axillary Temperature day 0 day 1 day 2 day 3 day 7 day 14 day 21 day 28 day 35 day 42 day 63
Secondary Outcome piperaquine and lumefantrine concentrations 5 timepoints/patient from days 0 to 63
Secondary Outcome Hemoglobin concentration Day 0 Day 3 Day 7 Day 28 Day 42 Day 63
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Manhiça District Hospital Manhica Mozambique
Chikhwawa District Hospital Chikhwawa Malawi
Queen Elizabeth Central Hospital Chipatala Avenue Blantyre BT3 Malawi
St Paul¿s District Hospital Nchelenge Province Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
European & Developing Countries Clinical Trials Partnership (EDCTP) 334 Laan van Nieuw, Oost Indië The Hague 2509 AA
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Pembroke Place Liverpool L3 5QA United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Dr Modest Mulenga Tropical Diseases Research Centre, 6th & 7th Floor of Ndola Central Hospital Building, Corner of Nkana and Broadway Roads Ndola Zambia
Dr Mike Chaponda Tropical Diseases Research Centre, 6th & 7th Floor of Ndola Central Hospital Building, Corner of Nkana and Broadway Roads Ndola Zambia
Dr Esperança Sevene Rua 12, Cambeve, Vila da Manhiça Manhiça CP 1929 Mozambique
Dr Eusebio Macete Rua 12, Cambeve, Vila da Manhiça Manhiça CP 1929 Mozambique
Dr Esperança Sevene Rua 12, Cambeve, Vila da Manhiça Manhiça CP 1929 Mozambique
Dr Abel Nhama Rua 12, Cambeve, Vila da Manhiça Manhiça CP 1929 Mozambique
Dr Denise Naniche Barcelona Centre for International Health Research, Carrer Rosselló 132 Barcelona E-08036 Spain
Professor David Lalloo Liverpool School of Tropical Medicine, Pembroke Place Liverpool L3 5QA United Kingdom
Dr Dianne Terlouw Liverpool School of Tropical Medicine, Pembroke Place Liverpool L3 5QA United Kingdom
Dr Saye Khoo Liverpool School of Tropical Medicine, Pembroke Place Liverpool L3 5QA United Kingdom
Mr Arthur Ricky Kang¿ombe Liverpool School of Tropical Medicine, Pembroke Place Liverpool L3 5QA United Kingdom
Dr. Brian Faragher Liverpool School of Tropical Medicine, Pembroke Place Liverpool L3 5QA United Kingdom
Dr Mavuto Mukaka Malawi-Liverpool Wellcome Trust Clinical Research Programme, 1 Chipatala Avenue Blantyre BT3 Malawi
Professor Robert Heyderman Malawi-Liverpool Wellcome Trust Clinical Research Programme, 1 Chipatala Avenue Blantyre L3 5QA Malawi
Professor Feiko ter Kuile Liverpool School of Tropical Medicine, Pembroke Place Liverpool L3 5QA United Kingdom
Professor Umberto D'Alessandro Institute of Tropical Medicine, Nationalestraat 155 Antwerp 2000 Antwerp Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Victor Mwapasa vmwapasa69@gmail.com +265 999981496 1 Mahatma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre BT3 Malawi Associate Professor
Role Name Email Phone Street address
Public Enquiries Helen Wong H.Wong@liverpool.ac.uk +44(0)151 705 3346 Pembroke Place
City Postal code Country Position/Affiliation
Liverpool L3 5QA United Kingdom Administrative Officer
Role Name Email Phone Street address
Scientific Enquiries Victor Mwapasa vmwapasa69@gmail.com +265 999981496 1 Mahatma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre BT3 Malawi Associate Professor
REPORTING
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