Protocol No. 01.05.2017 Confidential JULY 4, 2017 MUHAS/ KAROLINSKA INSTITUTET /UPPSALA UNIVERSITY Clinical Research Protocol “Aiming at prolonging the therapeutic life span of artemisinin-based combination therapies in an era of imminent Plasmodium falciparum resistance in Bagamoyo District, Tanzania - new strategies with old tools”. DR. LWIDIKO EDWARD MHAMILAWA- PHD STUDENT MUHAS Muhimbili University of Health and Allied Sciences Version Date: 04th July 2017 Page 1 of 92 Protocol No. 01.05.2017 Confidential MUHAS/ KAROLINSKA INSTITUTET /UPPSALA UNIVERSITY Clinical Research Protocol “Aiming at prolonging the therapeutic life span of artemisinin-based combination therapies in an era of imminent Plasmodium falciparum resistance in Bagamoyo District, Tanzania - new strategies with old tools”. Protocol Number: 01.05.2017 – ALU -PQ Version Date: 04th July 2017 Version 05 Investigational Product: Artemether-Lumefantrine and Primaquine Development Phase: Phase IV Sponsors: Muhimbili University of Health and Allied Sciences; Dept. of Parasitology and Medical Entomology P. O. Box 65001 Upanga, Dar es salaam Tanzania, Karolinska Institutet, Dept of Molecular, Tumor and Cell Biology, Nobelsväg 16 171 77 Stockholm, Sweden Uppsala University, Dept. of Women's and Children's Health, IMCH, Drottninggatan 4, 75310 Uppsala Sweden Funding Organization: Swedish International Development Agency (SIDA) & Swedish Research Council Principal Investigator: Name: Dr. Lwidiko Edward Mhamilawa Telephone: +255712865206 Fax: E-mail:
[email protected] Version Date: 04th July 2017 Page 2 of 92 Protocol No. 01.05.2017 Confidential Co-investigators / Name: Dr. Billy Ngasala supervisors: Address: P.O Box 65011 DSM Mobile: 0754316359 Email:
[email protected] Name: Prof. Anders Bjorkman Address: Solnavägen 1, 171 77 Solna, Sweden Mobile: +46 (0) 8-524 868 29.