List of Approved Clinical Trials in Tanzania:
S/N Study Title Condition Intervention Principal Investigator Location Sponsor
1. A randomized, Observer-blind, Placebo-Controlled, Two-part, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Prime-Boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo Ebola Ad26.ZEBOV and MVA-BN-Filo Dr. Nyanda Elias Ntinginya NIMR - MMRC P.O. Box 2410, Mbeya, Tanzania NIMR-Mbeya Medical Research Centre (MMRC) P.O. Box 2410, Mbeya, Tanzania Janseen Vaccines & Prevention B.V
2. A Phase 2b Study to Evaluate the Safety and Efficacy of VRC01 broadly neutralising monoclonal antibody in reducing acquisition of HIV-1 infection (HVTN 703/HPTN081) HIV Infection VRC01 Dr. Lucas Maganga NIMR - MMRC P.O. Box 2410, Mbeya, Tanzania NIMR-Mbeya Medical Research Centre (MMRC) P.O. Box 2410, Mbeya, Tanzania Division of AIDS, National Institute of Allergy and Infectious Disease, US National Institute of Health
3. A Side by Side Comparison of Transvaginal Colposcope to Standard of Care Cervicography in a 50 - patients pilot study on women undergoing cervical cancer screening Cervical Cancer Transvaginal Digital Colposcope Dr. Olela Oneko Kilimanjaro Christian Centre (KCMC), Duke Collaboration - RHC Unit, P. O. Box 3010, Moshi, Tanzania DUKE UNIVERSITY
4. Dyadic Based Diagnosis, Care & Prevention HIV Discondant Couple in Tanzania HIV Infection HIV-Test Kits (Oral Quick Rapid HIV 12 Antibody Assay) Dr. Jessie Mmbwambo, Muhimbili University of Health and Allied Sciences, Department of Psychiatry and Mental health, P.O.Box 65001, DAR ES SALAAM Muhimbili University of Health and Allied Sciences, Department of Psychiatry and Mental health, P.O.Box 65001, DAR ES SALAAM National Institute Mental Health NIMH-USA
5. A dose reduction Immunobridging and Safety Study of Two HPV Vaccine in Tanzanian Girls Human Papilloma Virus Cervarix? and Gardasil-9? (HPV Prophylactic Vaccines) Dr John Changalucha Mwanza Intervention Trials Unit (MITU), National Institute for Medical Research (NIRM), P.O. Box 11936, Mwanza Mwanza Intervention Trials Unit (MITU), National Institute for Medical Research (NIRM), P.O. Box 11936, Mwanza London School of Hygiene and Tropical Medicine
6. IMPAACT P1026s: Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum HIV Efavirenz, Tenofovir Lopinavir/Ritonavir, first line TB drugs, 3. Second line TB drugs, 5. Ethinyl estradiol, etonogestrel and other progestins James samwel Ngocho Kilimanjaro Christian Medical Centre (KCMC), DUKE University Kilimanjaro AIDS Program Sokoine Road, CCFCC Building, Box 3010 Moshi Department of Health & Human services National Institute of Health National Institute of Allergy and Infectious Diseases Division of AIDS 6100, Executive Blvd, Room 4B11 Bethesda, Maryland 20892 6700-B Rockledge
7. Febrile Illness Surveillance in Northern Tanzania febrile illness Biofire Defence Film Array Instrument Dr Venance Maro Kilimanjaro Christian Medical Centre (KCMC), DUKE University Kilimanjaro AIDS Program Sokoine Road, CCFCC Building, Box 3010 Moshi National Institute of Health (NIH)-US
8. Randomized clinical trial to assess whether the duration of cotrimoxazole preventive therapy in HIV patients with CD4 counts less tha 350 cells/ul by antiretroviral treatment influences the rate of carriage of multdrug-resistant bacteria Methicillin-resistant Staphylococcus aureus Co-trimoxazole tablet Dr Joel Manyahi Muhimbili University of Health and Allied Sciences P.O. Box 65001, Dar es Salaam. Muhimbili National Hospital, P.O. Box 65000, Dar es Salaam Muhimbili University of Health and Allied Sciences, P.O. Box 65001, Dar es salaam
9. Prospective study of Lopinavir based ART for HIV infected children globally (LIVING STUDY) HIV Infection Lopinavir and Ritonavir Oral Pellets Dr Nzovu Ulenga 1. Amana district hospital: P. o. box 25411, DAR ES SALAAM 2) Temeke Regional Hospital, P.O.Box 45232, DAR ES SALAAM 3) Chronic Diseases Clinic of Ifakara, Ifakara health Institute, Mlabani passage, PO Box 53, Ifakara, morogoro DNDi, Chemin Louis Dunant, 15.1202 GENEVA,SWITZERLAND TELL No +41 22 906 9230
10. An evaluation of a combination HIV prevention intervention that includes oral PrEP for adolescent girl and young women in south africa and tanzania HIV Infection Truvada? (Emtricitabine/Tenofovir disoproxil fumarate) Dr Said Kapiga Mwanza Intervention Trials Unit, National Institute for Medical Research, P.O. Box 11936, Mwanza Mwanza Intervention Trials Unit, National Institute for Medical Research, P.O. Box 11936, Mwanza Wits Health Consortum (Pty) Ltd, South Africa
11. A multi-country prospective clinical safety of subjects exposed to the candidate Ebola vaccine Ad26.ZEBOV and /or MVA-BN-Filo Ebola Ad26.ZEBOV and /or MVA-BN-Filo Dr George PrayGod National Institute for Medical Research (NIMR), Mwanza, Tanzania Isamilo Road P.O.Box 11462, Mwanza, Tanzania Mwanza Intervention Trials Unit (MITU), National Institute for Medical Research (NIRM), P.O. Box 11936, Mwanza Janssen Vaccines & Prevention B.V 920 Routes 202 Raritan, NJ 08869 United State of America
12. Antibiotics for Children with Severe Diarrhea (ABCD) Trial Diarrhoea Ciprofloxacin and Azithromycin Professor Karim P. Manji, Department of Paediatrics and Child Health Muhimbili University of Health and Allied Sciences, P.O.Box 65004, DAR ES SALAAM Mbagala Rangitatu, Mbagala Round table, Temeke, Mwananyamala and Amana District hospitals and Muhimbili National Hospital World Health Organization (WHO), Avenue Appia 20, 1211, Geneva 27, Switzerland
13. Establishing the optimal dose of therapeutic zinc supplementation for the treatment of acute diarrhea in under five children ? a dose response trial in South Asian and a Sub-Saharan African Setting (aka ZTDT) Diarrhoea Elemental Zinc Sulphate - 5mg and 10 mg Professor Karim P Manji These sites are large district hospitals in Dar es Salaam and we have conducted multiple studies and clinical trials. Raritan, NJ 08869
14. IMPAACT 2010 Phase III Study of virologic efficacy and safety of Dolutegravir containing versus efavirenz-containing Antiretroviral therapy Regimens in HIV-1-Infected Pregnant Women and theire Infants Versin 1.0, 1 December 2016 HIV Infection Dolutegravir Dr James Samwel Ngocho KCMC-Duke University AIDS Collaboration, P.O.Box 3010 MOSHI National insitute of Allergy and infectious diseases and NICHD
15. INVICTUS Trials Investigation of rheumatic Atrial Fibrillation Treatment using vitamin K anatgonists, rivaroxaban or Aspirin Studies rheumatic Atrial Fibrillation Rivaroxaban Dr. Pilly 1) MUHAS Academic Medical Centre 2) JKCI 3) Dodoma Hospital 4) Mbeya Hospital Hamilton Health Sciences, Hamilton, ON, Canada.
16. ELICIT Early life intervention for childhood growth and development in TANZANIA Growth Nicotinamide . Azithromycin and Nilazoxamide Estomiah Mduma Hydom-Global Health Research Centre Timothe Burra P.O.Box 9000 Hydom manyara
17. IPTp with dihydroartemisinin-piperaquine and azithromycin for malaria, sexually transmited and reproductive tract infections in pregnancy in high sulphadoxine-pyrimethamine resistance area in Kenya,malawi and tanzania an inernational multcenter 3-arm placebo-controlled trial(IMPROVE) MALARIA Dihydroartemisinin-piperaquine and azithromycin Prof John Lusingu National Institute for Medical Research (NIMR), Korogwe Research Station, P.O. Box 210, Korogwe, Tanga. 1)National Institute for Medical Research (NIMR), Korogwe Research Station, P.O. Box 210, Korogwe, Tanga. 2)Korogwe District Hospital (KDH) and Handeni district hospital 3)Kilimanjaro Christian Medical Centre (KCMC) in Moshi Liverpool school of tropical medicine(LSTM)
18. A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (Vcp2438) and MF50?-or AS01B -adjuvanted clade C Env protein, in healthy, HIV-Uninfected adult participants (HVTN 120) HIV infection ALVAC-HIV (Vcp2438) and MF50?-or AS01B -adjuvanted clade C Env protein Dr. Winstom William NIMR-Mbeya Medical Research Centre (MMRC) Division of AIDS, National Institute of Allergy and Infectious Diseases US department of Health and Human Services
19. IMPAACT 2005: A phase I/II open-label, single-arm study to evaluate the pharmacokinetics, safety and tolerability of Delamanid in combination with optimized multidrug background Regimen (OBR) for Multi-Drug resistant Tuberculosis (MDR-TB)in HIV-infected and HIV-Uninfected children with MDR-TB TB Delamanid Dr. Cynthia Asiyo Kilimanjaro Christian Medical Center-Duke University AIDS Collaboration, P.O.Box 3010, Sokoine Road, Moshi - National institute of child health and human development (NICHD)
20. Cepheid Genexpent omni combined with the Xpert MTB/RIF utra for detection of tuberculosis and Rifampicin resistance in adults with preventive pulmonary tuberculosis at primary level diagonostic Centre in Tanzania,a pragnatic cluster,randomazed controlled trial(short tittle:Omni/Utra trial) TB Xpert MTB/RIF utra Dr. Fredrick Haraka, Ifakara Health Institute-Bagamoyo Primary health care facilities in Bagamoyo district and Kinondoni District to represent rural and urban areas.Kimara, Mburahati, Mbezi ,Tegeta ,Msata ,Kiwangwa ,Bunju ,Kunduchi , Kawe ,Makuburi ,Pande ,Miono ,Ubena Estate and St Elizabeth dispensaries Foundation for Inovative new Diagnostics
21. The development and evaluation of informed HIV self testing intervention among hard to reach adults in Northern Tanzania HIV Oral Quick ADVANCE? Rapid HIV-1/2 Antibody Test Dr. Aisa Shayo Kilimanjaro Clinical Research Institute Duke Global Health Institute, 1341 Connecticut Avenue, NW Suite 2. Washington, D.C. 20036 USA
22. Field trial to evaluate the safety and efficacy of cysvax? recombinant porcine cysticercosis vaccine in pigs kept under field conditions in Tanzania Cysticercosis cysvax? Vaccine Dr. Elisante Makundi, The Open University of Tanzania P.O Box 23409 Dar es Salaam USDM-babati and Hanang regions Global Alliance for veterinary Medicine
23. A Phase Ib age de-escalation dose-escalation randomised, double-blind, controlled study of the safety and immunogenicity of heterologous prime-boost with the candidate malaria vaccines ChAd63 RH5 and MVA RH5 administered intramuscularly according to a 0, 2-month vaccination schedule in healthy adults, young children and infants in Tanzania. malaria ChAd63 RH5 and MVA RH5 Dr. Ally Olotu Ifakara Health Institute-Kingani Estate phase I Unit University of Oxford, Old Road, Headington, Oxford, OX3 7JT
24. Clinical Trial to evaluate the safety, immunogenicity and efficacy of direct venous inoculation of Plasmodium Falciparum sporozoite vaccine (PfSPZ vaccine) in HIV negative and HIV positive Tanzanian adults malaria PfSPZ vaccine Dr Said Jongo Ifakara Health Institute-Kingani Estate phase I Unit Sanaria Inc. USA
25. Doxycycline 200mg/d vs 100mg/d for 6 weeks to improve filarial lymphedema - a multinational,double blind,randomized,Placebo-controlled trial Filariasis Doxycycline Dr. Upendo Mwingira, National Institute for Medical Research, 3 Barack Obama Drive, P.O.Box 9653, 11101 Dar es Salaam 1)Sokoine Regional Referral Hospital P.O.Box 1011 Lindi 2)Tumbi regional Referral Hospital (TDRRH) P.O.Box 30041 Kibaha National Institute for Malarial Research
26. Evaluation of SAMBA Semi-Quantitative Point-of-Care (POC) Viral load test for Antiretroviral therapy Monitoring in Moshi, Municipal Tanzania (SAMBA-01). HIV Infection SAMBA II Semi Q-HIV Point Of Care Viral Load assay Dr Ireen Kiwelu, Kilimanjaro Christian Medical Centre (KCMC), Pasua and Majengo Health Clinics, P.O. Box 2236, KILIMANJARO. KCMC, Majengo and Pasua Health Centres in Moshi town. DANIDA Building Stronger Universities (BSU3) Centre for Medical Parasitology Department of Immunology and Microbiology University of Copenhagen Faculty of Health and Medical Sciences Blegdamsvej 3B, Building 07-11-50, 2200 Copenhagen N