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    • Application(array)
      • id778
      • user_id81
      • trial_status_id5
      • abstract_of_study<p>\n In July 2016, the demand for yellow fever (YF) vaccines in response to the large urban outbreaks occurring concurrently and the risk of further spread through Africa and to Asia was larger than the available global supply. In this situation, the World Health Organization (WHO) developed recommendations for the use of fractional doses of YF vaccine as a dose-sparing strategy. These recommendations were based on data from a limited number of clinical trials, none of which had been conducted in Africa. Additional studies were initiated to assess the applicability of fractional doses to all four WHO-prequalified YF vaccines with respect to vaccine immunogenicity in adults and children in Africa, including HIV positive adults. One such study, comparing full standard dose to 1/5^th of standard dose of all four WHO-prequalified YF vaccines in adults (Clinicaltrials.gov number: NCT02991495), is currently ongoing at KEMRI CGMRC (see SERU protocol 3452) and Epicentre, Mbarara (UNCST HS 2237) and is designed to answer questions on the use of current stock of YF vaccines with a potency as close as possible to each manufacturers’ minimum release. Data from this trial will inform a WHO recommendation on using 1/5^th of the current standard dose of vaccine for outbreak control.  However, since many vials will contain excess YF vaccine such that 1/5^th of a vial is likely to be substantially above the current minimum potency requirements, these data may not be scientifically explanatory regarding the minimum dose required for preventive use.</p>\n<address>\n Here, in this new complementary study, we aim to determine the lowest YF vaccine dose that is non-inferior to the current standard full dose among populations in sub-Saharan Africa. The study will be conducted in Kenya (KEMRI CGMRC, Kilifi) and Uganda (Epicentre, Mbarara) with trial participants recruited at both sites, using vaccine from one WHO-prequalified manufacturer (Institut Pasteur de Dakar, Senegal). Our primary aim is to compare the immunogenicity of full standard dose of vaccine with three lower doses in adults, using seroconversion at 28 days post-vaccination, measured by plaque reduction neutralization assay (PRNT₅₀), as the endpoint. Adult participants (n=480) will be randomized for vaccination with full standard dose or with approximately 1000, 500 or 250 IU of vaccine (i.e. 4 arms, 1:1:1:1 allocation ratio). Safety and immunogenicity results will then be reviewed by the study DSMB, and the lowest non-inferior dose selected for assessment in a sub-study in children (n=420) in comparison to full standard dose (i.e. 2 arms, 1:1 allocation ratio). Secondary objectives will include immunogenicity at 10 days, 1 year and 2 years post-vaccination, assessment of the influence of cross-reactive antibodies to other flaviviruses on vaccine immunogenicity, assessment of T and B cell immune responses, assessment of virological and immunological kinetics and occurrence of serious adverse events (SAE). In addition, we will assess the range of views and perceptions of key stakeholders in vaccine policy and implementation on lower vaccine dose usage during YF epidemics and routine use. We expect the data from this qualitative study to inform the implementation of policies relating to low-dose vaccine usage for the control of YF and other diseases (e.g. pneumococcal vaccines) where such strategies are in consideration.</address>\n<p>\n  </p>\n
      • study_title<address>\n <p>\n <em>Non-Inferiority Fractional-Doses Trial For Yellow Fever Vaccine</em></p>\n <p>\n  </p>\n</address>\n
      • laymans_summary<p>\n Lay Title: A trial to determine the safety and immune response elicited by the reduced doses of yellow fever vaccine in comparison to full dose of the vaccine in Kenyan and Ugandan adults and children What is the problem/background? Yellow fever (YF) is a disease caused by a mosquito-borne flavivirus that is endemic in sub-Saharan Africa and tropical South America. YF virus infection can cause mild or severe illness, leading to jaundice, kidney failure, bleeding and death. The YF vaccine is shown to be very effective for disease control, including prevention of YF outbreaks. However insufficient vaccine is produced for routine use, and whilst a YF vaccine stockpile is reserved for outbreak control, this is frequently depleted. Measures to increase the global supply of YF vaccine are urgently needed. What questions are we trying to answer? The World Health Organization (WHO) has recommended consideration of using fractions of standard YF vaccine dose to be able to vaccinate more individuals with a given quantity of vaccine in outbreak situations when there are insufficient doses to vaccinate the population at risk. However, the actual minimal dose of YF vaccine needed to elicit an immune response has not been determined. In this study, we will assess whether the immune response and adverse events occurring after vaccination of adults and children with the standard full dose of YF vaccine are comparable to those observed after vaccination with one of three lower doses of vaccine aiming to establish a minimal dose. Further, to support the implementation of a future YF control strategy using lower doses of vaccine, we will evaluate the views and perceptions of different stakeholders involved in national or international vaccine policy regarding the use of lower doses of the YF vaccine. Where is the study taking place, how many people does it involve and how are they selected? The vaccination study will take place in Kilifi, Kenya and Mbarara, Uganda among healthy adults and children who have previously not had the YF vaccine and/or YF infection and have no contraindications for vaccination. In total, 480 adults (240 at each site) and 420 children aged 9 months to 5 years (210 at each site) will be included. To evaluate views and perceptions on the use of fractional YF vaccine doses we will approach and conduct discussions and interviews with various stakeholders in national vaccine policy in Kenya, Uganda, Senegal and other international institutions. What does the study involve for those who are in it? Participants who have previously not had the YF vaccine and/or YF infection will be screened for any significant health problems. Those found eligible to participate will then be randomized to receive a single dose of the standard full dose of YF vaccine (group 1) or any of the three lower doses (groups 2 to 4). Participants will then be required to attend follow up visits to have blood taken for tests to measure immune response to vaccination, the level YF vaccine in the body, and to be asked about any side effects. Vaccine policy stakeholders included in the study will be requested to participate in interviews at their convenience. What are the benefits and risks/costs of the study for those involved? The risks relate to the possibility of developing an allergic or other reaction upon administration of the YF vaccine. Serious adverse reactions to the vaccine are, however, rare. There are no immediate health benefits to individuals participating in this study other than information about their health. If there was a YF outbreak in the future, participants getting the full YF vaccine dose would be expected to be protected and there is a chance that participants who receive the lower dose would be protected against infection. We are not able to issue YF vaccination certificates to participants at the point of vaccination. If the participant travels to endemic areas and needs a YF vaccination certificate for proof of vaccination, they will be advised to be revaccinated at an authorized health facility in Kenya or Uganda, respectively. However, on completion of the study we will offer participants the possibility to receive a YF vaccination certificate. No safety concerns are reported with multiple doses of the vaccine. The vaccine policy stakeholders participating in the study will not be at any risk associated with the vaccine trial. Any costs they incur during the process of the study will be reimbursed as out of pocket expenses. How will the study benefit society? If any of the lower YF vaccine doses safely elicits immune response that are comparable to the full vaccine dose, then in effect this finding could have an impact on the number of doses that are produced, and substantially increase the number of doses that can be given based on the world’s currently available vaccine stock, and thereby enhance our ability to prevent and control YF outbreaks. The results from the interviews and discussions with vaccine policy stakeholders will support the development of a strategy to implement the use of lower YF vaccine doses for disease control. When does the study start and finish? The study will start upon receipt of ethical approval and will be completed 40 months later.</p>\n
      • short_titleNIFTY
      • protocol_noECCT/19/03/04
      • version_noVersion 1.3
      • date_of_protocol04-03-2019
      • study_drugYellow Fever Vaccine
      • disease_conditionYellow fever
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@kemri-wellcome.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum0
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      • applicant_complete_form(null)
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      • applicant_pictorial_sample1
      • applicant_gcp_training1
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      • applicant_indemnity_pi0
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      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDerick Kimathi
      • declaration_date119-03-2019
      • declaration_principal_investigatorGeorge Warimwe
      • declaration_date219-03-2019
      • placebo_presentNo
      • study_objectives<p>\n Primary objective To determine the lowest dose (1000, 500 and 250 IU/dose) of YF vaccine that is non-inferior to the full standard dose as measured by seroconversion using the PRNT50 assay at 28 days post-vaccination in an adult population. Secondary objective(s) • To describe the geometric mean PRNT50 titre (GMT) at 10 days, 28 days, 1 year and at 2 years post-vaccination of the different doses of the YF vaccine. • To describe the change in PRNT50 titre (i.e. the geometric mean fold increase (GMFI) as a continuous variable) between baseline and day 28 after vaccination with the different doses of the YF vaccine. • To map out key stakeholders’ priorities and perceptions regarding a change in policy towards the use of fractional doses of YF vaccine and their potential influence on policy process. • To measure neutralising antibody to other flaviviruses (including dengue, West Nile and zika viruses) on the baseline sample and determine the impact of these antibodies on YF vaccine immunogenicity. • To assess post-vaccination control of viremia by vaccine dose on samples collected at baseline, and on days 2, 3, 4, 5, 6, 7 and 10 after vaccination. • To determine the change in T and B cell immune responses between baseline and days 10 and 28 post-vaccination. • To determine the change in serum cytokine and chemokine levels between baseline and days 2, 3, 4, 5, 6, 7, 10 and 28 post-vaccination • To assess the occurrence of adverse events (AE) over 28 days after vaccination and serious adverse events throughout the duration of the study.</p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Individuals aged ≥18 - <60 years of age.\n <ul>\n <li>\n For the sub-study, children aged between 9 months and 5 years.  </li>\n </ul>\n </li>\n <li>\n HIV status</li>\n <li>\n HIV negative on serological screening OR</li>\n <li>\n HIV positive adults and children aged > 18 months on serological testing, and no symptoms suggestive of current clinical immunosuppression and CD 4 count>200 (for adults) and CD4% > 25% (for children aged <5 years) within the last 6 months.</li>\n <li>\n Ability to provide informed consent to participate in the study</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ul>\n <li>\n Known contraindications to YF vaccination such as allergies to egg protein and chicken products or any component of the vaccine (including gelatin, eggs, eggs products or chicken products), immunodeficiency, known thymus disorder, such as thymoma and myasthenia gravis</li>\n</ul>\n<ul>\n <li>\n Using corticosteroids or other immunosuppressive therapy</li>\n <li>\n Thymus disorder, such as thymoma and myasthenia gravis</li>\n <li>\n Acute febrile disease on the day of vaccination with temperature >37.5 degrees Celsius is a temporal contraindication.</li>\n <li>\n Previous YF vaccination</li>\n <li>\n Previous YF infection as determined from history</li>\n <li>\n Pregnancy (as determined by a urine test on the proposed day of vaccination) and lactating women</li>\n <li>\n Planning to migrate out of the study areas before the end of the study follow-up</li>\n <li>\n Planning to travel to a country requiring YF vaccination certificate within the first year after vaccination.</li>\n <li>\n Any condition or criteria, including acute or chronic clinically significant abnormality that in the opinion of the investigator might compromise the wellbeing of the volunteer or interfere with the outcome of the study.  </li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n To determine the lowest dose (1000, 500 and 250 IU/dose) of YF vaccine that is non-inferior to the full standard dose as measured by seroconversion using the PRNT₅₀ assay at 28 days post-vaccination in an adult population.</p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Kilifi Capacity – 15 Staff</p>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<ol>\n <li>\n George Warimwe – Principal Investigator</li>\n <li>\n Derick Kimathi – Co PI</li>\n <li>\n Philip Bejon – Sponsor Representative</li>\n <li>\n Sassy Molyneux - Qualitative study, design, analysis, interpretation of results and publication.</li>\n <li>\n Mainga Hamaluba - Head of Clinical Trials facility, data quality control, assurance and analysis, interpretation of results and publication.</li>\n <li>\n Henry Karanja - Sample preparation and storage, lab assays and analysis, interpretation of results and publication.</li>\n <li>\n John Gitonga - Sample preparation and storage, lab assays and analysis, interpretation of results and publication.</li>\n <li>\n Marianne Munene - Regulatory affairs contact</li>\n <li>\n Jackline Wafula – Project Management</li>\n <li>\n Jimmy Shangalla - Pharmacist</li>\n <li>\n Naomi Kamau – Trial Nurse</li>\n <li>\n Jane Mwendwa – Trial Nurse</li>\n <li>\n Kenneth Kiogora - Trial Clinician</li>\n <li>\n Felix Moki – Trial Clinician</li>\n <li>\n Stanley Cheruiyot – Data Management</li>\n</ol>\n<p>\n  </p>\n<p>\n Uganda – Mbarara Site</p>\n<p>\n  </p>\n<p>\n Patrick Kazooba – PI for Mbarara Site</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Yellow fever (YF) is a disease caused by a mosquito-borne flavivirus that is endemic in sub-Saharan Africa and tropical South America. Ninety percent of YF cases are in Africa</p>\n
      • other_details_regulatory_notapproved<p>\n In Uganda the protocol will be submitted to Mbarara University of Science and Technology Research Ethics Committee (MUST-REC). The protocol will also be submitted to the national body, Uganda National Council for Science and Technology (UNCST) as well as the regulator body, National Drug Authority (NDA).</p>\n
      • other_details_regulatory_approved<p>\n Approval from NDA has not yet been received. The trial will be conducted in one site in Uganda</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration40 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorFull dose of yellow fever
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Kilifi
      • single_site_physical_addressIAVI Clinic
      • single_site_contact_personDerick Kimathi
      • single_site_telephone0727161778
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_statesTwo
      • number_of_sites
      • multi_country_listKenya\nUganda
      • data_monitoring_committeeYes
      • total_enrolment_per_site450 Kilifi\n
      • total_participants_worldwide900
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren between 9 months and 5 years, parental consent will be obtained
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameGeorge
      • investigator1_middle_name
      • investigator1_family_nameWarimwe
      • investigator1_qualificationPhD
      • investigator1_professional_addressP.O Box 230, Kilifi 80108, Kenya
      • investigator1_telephone+254 708257982
      • investigator1_emailGWarimwe@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants450 (240 adults, 210 children)
      • notification<p>\n None</p>\n
      • approval_date21-06-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-02-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
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      • admin_stopped_reason(null)
      • approved2
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      • balance_site(null)
      • final_date(null)
      • modified2025-07-25 12:30:03
      • created2019-03-18 16:08:09
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id486
        • application_id778
        • given_nameGeorge
        • middle_name
        • family_nameWarimwe
        • qualificationPhD
        • professional_addressP.O Box 230, Kilifi 80108, Kenya
        • telephone+254 708257982
        • emailGWarimwe@kemri-wellcome.org
        • created2019-03-18 16:14:19
        • modified2020-02-27 13:09:37
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        • id632
        • application_id778
        • county_id(null)
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        • created2019-03-18 16:14:19
        • modified2020-02-27 13:09:37
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id379
        • application_id778
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personPhilip Bejon
        • addressP.O Box 230, Kilifi 80108, Kenya
        • telephone_number+254 724445743
        • fax_number
        • cell_number+254 724445743
        • email_addressPBejon@kemri-wellcome.org
        • created2019-03-18 16:14:19
        • modified2020-02-27 13:09:37
  • 1(array)
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      • id777
      • user_id360
      • trial_status_id5
      • abstract_of_study<p>\n This study, entitled Clinical Evaluation of the FilmArray Global Fever (GF) Panel, is sponsored by BioFire Defense, LLC and aims to evaluate the clinical sensitivity and specificity of the assays comprising the FilmArray Global Fever Panel when used to test whole blood collected from individuals with acute febrile illness, when compared to a well-validated molecular-based method, in the intended use setting (reference or diagnostic laboratory). The intention is to use these performance data to support classification of the FilmArray GF Panel as an in vitro diagnostic (IVD) device by the U.S. Food and Drug Administration (FDA) and other comparable regulatory agencies. Whole blood will be collected prospectively from patients attending outpatient and inpatient departments of the health care facilities at Kisumu District Hospital, Kombewa Sub-District Hospital, Kisii District Hospital, Marigat District Hospital, Gilgil District Hospital, and Kenya Armed Forces Memorial Hospital (Mbagathi, Nairobi), where only enrollment and specimen collection will be performed. The subjects will be consented for blood draw and testing of pathogens that are commonly associated with febrile illnesses such as malaria, leishmaniasis, anthrax, leptospirosis, plague, paratyphoid fever, typhoid fever, tularemia, Crimean-Congo hemorrhagic fever, chikungunya fever, dengue fever, lassa fever, ebola virus disease, marburg virus disease, West Nile fever and Yellow fever. The collected blood sample will be labeled with only a study code number (SCN) in order to protect subject identity. However, in the event a select agent is detected twice using the Global Fever Panel, the enrollment log which links the SCN to the subject may be used to identify the subject for follow-up. The samples will be secured in refrigerators and freezers at WRP/KEMRI facilities and only study investigators and their authorized staff will have access. All safeguards ensuring privacy that are in place during this study period will also continue to be in place for the long-term storage of samples. Some tests planned for this trial will be done with our collaborating laboratories abroad. Before shipment of samples to such collaborating laboratories, authority for sample shipment and testing will be sought from KEMRI SERU. The collected specimens will either be tested fresh or will be frozen and then tested at a later date. Freezing of specimens will allow for continued collection of specimens when immediate testing is not possible. Freezing and testing of specimens will be tracked on study-specific forms. Informed consent will be obtained from eligible participants prior to specimen collection. For the study, up to 500 patients will provide 2.5-3.0 mL of whole blood and the blood sample will be labeled with a study code number (SCN). Continuous enrollment and testing are expected to last for approximately 18 months in order to achieve a required number of valid specimens. All FilmArray testing and nucleic acid extraction will occur at the Basic Science Lab, KEMRI/WRP, Kisumu. Of the 2.5-3.0 mL of whole blood collected, 500 L will be archived at ≤-70°C immediately for discrepancy testing. A 200 L aliquot of the whole blood will be used for FilmArray GF Panel testing. In addition to FilmArray testing, 800 L of the whole blood will be used to purify nucleic acid, using the provided MagNA Pure Compact system (or equivalent). The purified nucleic acids will be shipped frozen to BioFire Defense for further testing (comparator testing). Comparator assays are designed to amplify and detect pathogen nucleic acid; no genetic testing or specific amplification of human nucleic acid will be performed. The residual blood specimen will be stored refrigerated until FilmArray testing and nucleic acid extraction is complete in the event that additional testing/extraction is required. Once the required testing is completed, remaining sample (up to 2.0 mL total, which includes the 500 µl aliquot archived for discrepancy testing), will be archived at ≤-70°C for at least two years after study completion. In order to conduct future research utilizing these samples, a new sub-protocol must be written, reviewed and approved by both the WRAIR IRB and the KEMRI SERU. To maintain patient confidentiality, blood samples, blood sample aliquots and specimen nucleic acid will only be labeled with a study code number (SCN). This study will be performed according to the approved multisite protocol (attached), laboratory-specific protocols and site-specific workflow procedures, and available product literature for the FilmArray instrument and the MagNA Pure Compact system. No deviation from this protocol will be implemented without the prior review and approval of BioFire Defense and the respective sites’ IRB(s), except where it may be necessary to eliminate an immediate hazard to a research subject. The results of the FilmArray GF Panel testing will not be provided to the patients or their healthcare providers, or in any way be used to affect their standard of care except in the event that a true positive select agent detection is confirmed (see 3.4 below for full description). This study is jointly funded by the U.S. Army Medical Materiel Development Activity (USAMMDA) through contracts with BioFire Defense and managed by the Joint Program Executive Office for Chemical and Biological Defense – Medical Countermeasure Systems (JPEO-CBD-MCS), the National Institute of Allergy and Infectious Diseases (NIAID) and BioFire Defense. The clinical evaluation outlined in this protocol will be administered and managed by BioFire Defense. The Sponsor contact person(s) for this study will be at BioFire Defense, and are listed above (page i).  </p>\n
      • study_title<p>\n Clinical Evaluation of the FilmArray Gobal Fever GF Panel</p>\n
      • laymans_summary<p>\n Diseases that are associated with increased body temperature (fever more than ≥ 38 °C) and other clinical signs like headache, tiredness and muscle pain are many. They can be caused by different microorganisms that are widespread in different regions, including Kenya. Sometimes these diseases can occur as outbreaks that make many people ill. One of the big problems with these types of diseases is determining the cause of the disease because symptoms such as high temperature, headache, tiredness and muscle pain are common signs of many diseases. A machine that can quickly and correctly identify microorganisms in blood of patients with elevated temperature would make treatment decisions easier for doctors. The FilmArray Global Fever (GF) Panel has the potential to detect many of these diseases. It is a machine that works by multiplying genetic material of an organism, making such materials easier to detect. The system is able to detect bacteria, viruses, and protozoa in a single blood sample. Unlike other methods that require human intervention, the machine performs all manipulations including extraction of genetic materials, multiplication of genetic materials, and identification of microorganism. The process is fully automated and gives final results in approximately one hour. The purpose of this study is to test how good this machine is in detecting the following microorganisms in patients with fever: Leptospira spp., Plasmodium spp., Plasmodium falciparum, Plasmodium vivax/ovale, chikungunya virus, and dengue virus. To do this, the machine will be tested using blood samples that will come from an ongoing study that collects blood samples from patients with fever (KEMRI SSC #1282 and WRAIR #1402). The FilmArray test results of Detected or Not Detected will be compared to validated molecular-based methods that are performed at BioFire Defense, LLC in Salt Lake City, Utah, US. Data obtained in this study will be used to support application to license the FilmArray GF Panel as an in vitro diagnostic (IVD) device for detection of microorganisms in blood from patients with fever. If the proposed study is successful, the FilmArray GF Fever Panel may provide an effective way to obtain a quick diagnosis. The study is sponsored by a company called BioFire Defense, LLC and the study will be performed at the Basic Science Lab of the Kenya Medical Research Institute/ Walter Reed Project (KEMRI/WRP) in Kisumu.</p>\n
      • short_titleBiofire FilmArray Gobal Fever GF Panel
      • protocol_noECCT/19/03/03
      • version_noREV 05
      • date_of_protocol21-02-2018
      • study_drugBiofire FilmArray Gobal Fever GF Panel-Device
      • disease_conditionACUTE FEBRILE ILLNESS
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameBiofire FilmArray Gobal Fever GF Panel-Device
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdotigondi3@gmail.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data0
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license0
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan0
      • applicant_contractual_agreement0
      • declaration_applicantJohn Waitumbi +254 733616548
      • declaration_date115-03-2019
      • declaration_principal_investigatorJohn Waitumbi +254 733616548
      • declaration_date215-03-2019
      • placebo_presentNo
      • study_objectives<p>\n The objective of this multi-center study is to evaluate the clinical sensitivity and specificity of the assays comprising the FilmArray GF Panel when used to test whole blood specimens. It is hypothesized that the FilmArray GF Panel assays will be highly specific and give no false detections of the bacteria, viruses, and protozoa included in the panel. These data will be used to support submissions to the FDA in support of the FilmArray GF Panel as an in vitro diagnostic device.</p>\n
      • principal_inclusion_criteria<p>\n Febrile patient (>38 °C) recruited at a health facility One year or older Able to give consent (guardian if lees than 18 years) and assent if >13 years</p>\n
      • principal_exclusion_criteria<p>\n Not able to give consent or assent if of appropriate age</p>\n
      • primary_end_points<p>\n N/A</p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyDevice
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n The KEMRI/USAMRD-K Basic Science Laboratory (BSL) at Kondele is a research laboratory that performs multi-disciplinary basic science research (molecular biology and immunology) in malaria and many other infectious diseases, including disease surveillance, diagnostic evaluations and developments. BSL has a well developed basic science research infrastructure for performing: 1) Surveillance for pathogens associated with febrile illness in diverse eco-regions of Kenya; 2) Determination of malaria parasites population structure prior and post vaccine and drug intervention; 3) Evaluation of multi-pathogen diagnostic platforms for infectious diseases of regional and global importance. To perform these functions, BSL has a well developed research infrastructure that includes state of art technologies such as: 1) Real-time and conventional PCR for diagnosis and genotyping; 2) MAGPIX for multiplexing pathogen detection, ideal for outbreak investigations and disease surveillance studies; 3) Sanger sequencer for sequence generation and fingerprinting; 4) MiSeq for unbiased sequence screening and pathogen characterization. The Lab has a workforce of 13 well trained scientist that includes: • two senior scientists with PhDs • 5 Research Officers with MScs • One certified QA/QC officer with appropriate professional certification • 4 Assistant Research Officers with BSc degree • One data entry clerk/curator with BA. To support patient recruitment, the Lab has surveillance sites in 9 hospitals, each staffed with a clinical officer or nurse and a Lab technician</p>\n
      • other_details_explanation<p>\n n/a</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n The study has been submitted to anumber of countries and the RA in the respective countries have approved the study and the study is already ongoing in those countries. These include RA in Tanzania, Thailand , Cambodia, Uganda:Peru</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration18Months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI Walter Reed Project USAMRD A/K Kisumu
      • single_site_physical_addressBeside New Nyanza provincial Hospital
      • single_site_contact_personDr John Waitumbi
      • single_site_telephone+254 733616548
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states3 Africa , Asia and America
      • number_of_sites
      • multi_country_listMoshi, Tanzania\nSt Louis, USA\nBangkok, Thailand\nKampong Cham, Cambodia\nKampala, Uganda\nIquitos, Peru\n\nTegucigalpa, Honduras\nWashington, DC, USA\nNavrongo, Ghana\nTbilisi, Georgia\n
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwide1500
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJOHN
      • investigator1_middle_name
      • investigator1_family_nameWAITUMBI
      • investigator1_qualificationPhD
      • investigator1_professional_addressP.O BOX 54 KISUMU CODE 40100
      • investigator1_telephone+254 733616548
      • investigator1_emailjohn.waitumbi@usamru-k.org
      • organisations_transferred_No
      • number_participants500
      • notification<p>\n None</p>\n
      • approval_date16-05-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted28-09-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n This study, entitled Clinical Evaluation of the FilmArray Global Fever (GF) Panel aimed to evaluate the clinical sensitivity and specificity of the assays comprising the FilmArray Global Fever Panel when used to test whole blood collected from individuals with acute febrile illness, when compared to a well-validated molecular-based method, in the intended use setting (reference or diagnostic laboratory). The intention was to use these performance data to support classification of the FilmArray GF Panel as an in vitro diagnostic (IVD) device by the U.S. Food and Drug Administration (FDA) and other comparable regulatory agencies.</p>\n
      • implication_results<p>\n The Clinical Evaluation of the FilmArray Global Fever Panel in Kisumu Kenya was initiated July 10-18, 2019. A total of six (6) collections sites were trained to participate in the study as well as laboratory personnel to perform FilmArray testing and nucleic acid extractions. The last participant was recruited on 30th September 2019 bringing to a total of 163 subjects, of which 158 were enrolled and tested on FilmArray at Kisumu site. All eligible nucleic acids samples were shipped to BioFire Defense Laboratories after obtaining permission from KEMRI SERU. Comparator testing and analysis at BioFire Defense Laboratories has been completed. The first submission of Global Fever Panel results from all the participating sites was made to the FDA. The second submission with all the GFP analytes was made to FDA in October 2021. Full GFP analylates includes: Chikungunya virus, dengue virus (serotypes 1-4), Leptospira spp., Plasmodium spp., P. falciparum, and P. ovale/vivax. Crimean Congo Hemorrhagic Fever virus, Ebolavirus, Lassa virus, Marburgvirus, West Nile virus, yellow fever virus, Zika virus, Bacillus anthracis, Francisella tularensis, Salmonella enterica serovar Typhi and Paratyphi A, Yersinia pestis, and Leishmania donovani complex. A manuscript titled “Clinical evaluation of the BioFire Global Fever Panel for the identification of malaria, leptospirosis, chikungunya, and dengue from whole blood: a prospective, multicentre, cross-sectional diagnostic accuracy study by Manabe et al., The Lancet Infectious Diseases, 2022, https://doi.org/10.1016/S1473-3099(22)00290-0</p>\n
      • quantity_imported3 Film Arrays Global Fever (GF) Panel
      • quantity_dispensedN/A
      • quantity_destroyedN/A
      • quantity_exported 1 was returned to the sponsor because it was faulty
      • balance_site2 were donated to the site
      • final_date0000-00-00
      • modified2025-07-15 14:11:19
      • created2019-03-15 11:24:51
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id485
        • application_id777
        • given_nameJOHN
        • middle_name
        • family_nameWAITUMBI
        • qualificationPhD
        • professional_addressP.O BOX 54 KISUMU CODE 40100
        • telephone+254 733616548
        • emailjohn.waitumbi@usamru-k.org
        • created2019-03-15 12:18:07
        • modified2020-09-28 17:09:52
    • SiteDetail(array)
      • 0(array)
        • id631
        • application_id777
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-03-15 12:18:07
        • modified2020-09-28 17:09:52
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id378
        • application_id777
        • sponsorBioFire Defense, LLC
        • sponsor_typeIndustry
        • contact_personCynthia Phillips
        • address79 West 4500 South, Suite 14,
        • telephone_number(801) 262-3592 ext.1370
        • fax_number
        • cell_number(801) 262-3592 ext.1370
        • email_addressCynthia.Phillips@biofiredefense.com
        • created2019-03-15 12:18:07
        • modified2020-09-28 17:09:52
  • 2(array)
    • Application(array)
      • id771
      • user_id473
      • trial_status_id4
      • abstract_of_study<p>\n <span style=\"font-size:12px;\">The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travellers’ Diarrhoea (TD) in a deployed setting. In addition the study will explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed United States (US) and United Ki</span>ngdom (UK) military personnel.</p>\n
      • study_title<p align=\"center\">\n <span style=\"font-size:12px;\"><strong>A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial Evaluating Two Dose Regimens of Rifaximin (550 mg daily or 550 mg twice daily) for Chemoprophylaxis Against Travellers’ Diarrhoea (TD) Among Active Duty Deployed U.S. and British Military Personnel (PREVENT TD)</strong></span></p>\n
      • laymans_summary<h1>\n <span style=\"font-size:12px;\">The purpose of this study is to develop proof on the ability of 2 rifaximin medicines used for the prevention of Travellers’ Diarrhoea (TD) for military personnel sent to outer stations for different operations. In addition the study will try to find out the effect of the study medications on intestinal system's composition and antimicrobial resistance, and obtain any new information to help come up with a cost-effective use of medications used in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among military personnel from the United States (US) and United Kingdom (UK).</span></h1>\n<h1>\n  </h1>\n
      • short_titlePREVENT TD
      • protocol_noECCT/19/03/02
      • version_no6
      • date_of_protocol14-11-2016
      • study_drugrifaximin
      • disease_conditionDiarrhoea
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameXIFAXAN
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmargaretkoech@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african0
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantMargaret Koech
      • declaration_date108-03-2019
      • declaration_principal_investigatorMAJ Alexander Flynn
      • declaration_date208-03-2019
      • placebo_presentYes
      • study_objectives<h1>\n <span style=\"font-size:14px;\"><strong>OBJECTIVES AND SPECIFIC AIMS</strong></span></h1>\n<ol style=\"list-style-type:upper-roman;\">\n <li>\n <strong>Primary:</strong> To assess the efficacy of 550 mg rifaximin compared with placebo when taken twice daily (BID) or once-daily, by healthy subjects, to prevent TD.</li>\n <li>\n <strong>Secondary</strong>:\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n Safety of rifaximin when compared to placebo when taken to prevent TD.</li>\n <li>\n As a secondary objective, the efficacy of rifaximin vs. placebo will be evaluated in terms of an expanded series of endpoints (See secondary efficacy endpoints).</li>\n </ol>\n </li>\n <li>\n <strong>Exploratory:</strong>\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n Quantify the occurrence of rifaximin resistance (primary and acquired) among enteropathogens and commensal flora.</li>\n <li>\n Evaluate effect of rifaximin prophylaxis on the enteric microbiome.</li>\n <li>\n Evaluate the risk and biomarkers of a functional gastrointestinal disorder among subjects with TD compared to those with no TD during surveillance period.</li>\n <li>\n Estimate the efficacy of chemoprophylaxis in preventing TD-associated long-term health outcomes, specifically functional gastrointestinal disorders (FGD) and Reactive Arthritis (ReA).</li>\n <li>\n Evaluate the onset of TD after cessation of prophylaxis among subjects who remain at Country of Deployment (COD) beyond maximal prophylaxis period.</li>\n <li>\n Obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis strategy.</li>\n <li>\n Evaluate comparative efficacy of rifaximin in various geographic regions.</li>\n </ol>\n </li>\n</ol>\n<p style=\"margin-left:1.0in;\">\n  </p>\n<ol style=\"list-style-type:upper-roman;\">\n <li value=\"4\">\n <strong>Secondary Endpoints (Efficacy):</strong>\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n Secondary efficacy endpoints over the period of prophylaxis will include the proportion of subjects in each treatment group:\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n With TD</li>\n <li>\n With mild diarrhea</li>\n <li>\n With treated diarrhoea (TD and mild diarrhoea)</li>\n <li>\n With TD associated with isolation of a pathogen and pathogen type (invasive vs. enterotoxigenic <em>Escherichia coli</em> (ETEC) or other non-invasive pathogen-(only among subjects with appropriate samples to perform evaluation)</li>\n <li>\n Total diarrhoeal days</li>\n <li>\n Work days and performance loss due to diarrhoea, and</li>\n <li>\n Comparison of incidence of TD (TD event number and person-time risk)</li>\n </ol>\n </li>\n </ol>\n </li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n 1. A MODREC approved informed consent form is signed and dated.</div>\n<div>\n 2. Subject is at least 18 years of age.</div>\n<div>\n 3. Subject’s duration of prophylaxis will be at least 2 weeks.</div>\n<div>\n 4. Subject is capable of and willing to comply with all study procedures and available for the end of</div>\n<div>\n study visits and sample collection.</div>\n<div>\n 5. Women: Non-breast-feeding and negative urine/serum pregnancy test with understanding</div>\n<div>\n (through informed consent process) to avoid pregnancy while on study drug. Sole reliance on OCPs</div>\n<div>\n for birth control will not be recommended. Should an individual have a documented surgical</div>\n<div>\n sterilization in her medical record, a pregnancy test will not be required. If a volunteer becomes</div>\n<div>\n pregnant during the study, the principal investigator will notify the study research monitor and the</div>\n<div>\n MODREC/IRBs. The pregnancy outcome will be followed per IRB and other regulatory requirements</div>\n<div>\n for US and UK personnel.</div>\n
      • principal_exclusion_criteria<div>\n 1. Subject has hypersensitivity or allergy to rifaximin or rifampicin.</div>\n<div>\n 2. Subject has a concomitant disease or condition that could interfere with, or for which treatment</div>\n<div>\n could interfere with, the conduct of the study, or could in the opinion of the investigator increase the</div>\n<div>\n risk of AEs during the subject’s participation in the study</div>\n<div>\n 3. Subject is currently taking theophylline, digoxin, or warfarin.</div>\n<div>\n 4. Planned deployment length less than 6 weeks duration.</div>\n
      • primary_end_points<div>\n The primary objective of the study is to assess the efficacy of 550 mg rifaximin compared with</div>\n<div>\n placebo when taken twice daily (BID) or once-daily, by healthy subjects, to prevent TD.</div>\n<div>\n This will be assessed by review of the symptom memory aid with a study investigator to assess if</div>\n<div>\n travellers diarrhoea (defined in the study as >2 episodes of loose or liquid stool within 24 hours or 2</div>\n<div>\n episodes + associated sypmtom(s).</div>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n Study site</div>\n<div>\n The main study site will be the Medical Centre at LAB-E, British Army Training Unit, Kenya, in Nanyuki.</div>\n<div>\n This is a purpose built Medical Centre which supports British troops exercising in Kenya. It has full</div>\n<div>\n facilities for safe recruitment of subjects, and emergency treatment should this be required. It is</div>\n<div>\n staffed by 2 permanent Medical Officers. This will be augmented by the study team while the study</div>\n<div>\n is recruiting. Previously it has been used as a site for a large RCT which recruited over 150 subjects. It</div>\n<div>\n has clinical areas for recruitment of subjects, a monitored temperature secure pharmacy, facilities for</div>\n<div>\n secure storage of clinical records relating to subjects, resusitation facilties and equipment (and 24hour</div>\n<div>\n on-call medical personnel), and a clinical laboratory will be set up there.</div>\n<div>\n Personnel & related infrastructure</div>\n<div>\n The study team will be led by Major (Dr) Dan Burns and Col (Dr) Patrick Connor. Major Dan Burns</div>\n<div>\n has experience of being site PI for a large international RCT. Col Patrick Connor has led UK coordination</div>\n<div>\n of a large international RCT recruiting several hundred subjects. Both are GCP trained. In</div>\n<div>\n addition there will be a Kenya PI based out of USAMRU-K who will help liaise with the Kenya specific</div>\n<div>\n regulatory aspects of the trial.</div>\n<div>\n The study team consists of suitable qualified Medical Officers, nurses, and pharmacy support which</div>\n<div>\n will deploy to Kenya when the study is actively recruiting subjects. These individuals all hold current</div>\n<div>\n UK professional qualifications, are GCP trained and have specific training on the study protocol.</div>\n<div>\n An on-site pharmacy technician will ensure that Investigative Medical Product is stored, transported</div>\n<div>\n and dispensed safely and securely. They will be supported by a UK GCP trained pharmacist, Stephan</div>\n<div>\n D'Abreu-Hayling.</div>\n<div>\n A UK qualified biomedical scientist will oversee transport, storage and processing of clinical specimens.</div>\n<div>\n They will set up an on-site clinical laboratory which will perform initial processing and storing of</div>\n<div>\n specimens. Specimens (blood and stool) will be transported to the US by assured cold chain for</div>\n<div>\n further microbiological and other testing via the USAMRU-K laboratory. This process has previously</div>\n<div>\n been used successfully for clinical and research specimens.</div>\n<div>\n Study monitoring will be performed to assure the sponsor that the study is being conducted safely</div>\n<div>\n and in accordance with GCP principles and the protocol. David Mulvanney, an experience Nursing</div>\n<div>\n Officer, with GCP training and specific protocol and monitoring training will independently perform this</div>\n<div>\n function from the UK, supported will locally by the UK Military Senior Medical Officer, Kenya, and his</div>\n<div>\n team.</div>\n
      • other_details_explanation<div>\n The trial is testing prophylaxis against travellers' diarrhoea in UK soldiers. Kenya is a well established location for UK soldiers exercising</div>\n<div>\n overseas at the British Army Training Unit, Kenya. It means there are predictable numbers of soldiers deploying overseas to act as subjects</div>\n<div>\n for this travel trial, with data from previous studies showing a predictable rate of travellers diarrhoea (allowing power calculations).</div>\n<div>\n The applicant and sponsor are UK based, but will only recruit UK soldiers as subjects. Due to the nature of the trial we cannot conduct it in</div>\n<div>\n the UK, and Kenya is the best location for this research as outlined above, but also because of previous trials conducted, and establsihed</div>\n<div>\n connections with US Military colleagues at USAMRD-K.</div>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<div>\n Ministry of Defence Research Ethics Committee - UK Ethics Approval granted April 2017.</div>\n<div>\n Medicines & Healthcare Regulatory Agency - UK Competent Authority Approval granted April 2017.</div>\n<div>\n Uniformed Services University of the Health Sciences (USA) Instituitional Review Board Approval granted November 2014.</div>\n<div>\n Food and Drug Administration, exemption granted date XXXXXXX</div>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration2 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo; 550mg rifaximin
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaNyati Barracks, British Army Training Unit, Kenya
      • single_site_physical_addressNyati Barracks, Nanyuki, British Army Training Unit, Kenya, BFPO 680
      • single_site_contact_personMajor Dan Burns
      • single_site_telephone+447872966105
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listUS and Kenya
      • data_monitoring_committeeYes
      • total_enrolment_per_site235
      • total_participants_worldwide375
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLillian
      • investigator1_middle_name
      • investigator1_family_nameMusila
      • investigator1_qualificationPhD
      • investigator1_professional_address606, 00621, Village market, Nairobi, Kenya
      • investigator1_telephone+254-728-817872
      • investigator1_emaillillian.musila@usamru-k.org
      • organisations_transferred_No
      • number_participants235
      • notification<p>\n None</p>\n
      • approval_date10-06-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted27-02-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n The purpose of this study was to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travellers’ Diarrhoea (TD) in a deployed setting. In addition the study would explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed United States (US) and United Kingdom (UK) military personnel.</p>\n<p>\n  </p>\n
      • implication_results<p>\n  "This study's purpose was to develop evidence on use of 2 chemoprophylaxis regimens for the prevention of Travellers’ Diarrhoea (TD) in a deployed setting, as well as explore its effect on microbial flora and antimicrobial resistance. Its completion would essentially inform on the cost-effectiveness of use of chemoprophylaxis in prevention of TD as opposed to treatment of the illness in a deployed setting. This information would be used to develop management guidelines for TD among deployed United States (US) and United Kingdom (UK) military personnel.</p>\n<p>\n We however have no results to share on this outcome, since we did not get to participate in this trial due to the expiry of the sponsor's timeline requirements which we were unable to meet".</p>\n
      • quantity_importedN/A
      • quantity_dispensedN/A
      • quantity_destroyedN/A
      • quantity_exportedN/A
      • balance_siteN/A
      • final_date0000-00-00
      • modified2020-10-23 09:37:01
      • created2019-03-07 14:28:40
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id481
        • application_id771
        • given_nameFlynn
        • middle_name
        • family_nameAlexander
        • qualificationPhD
        • professional_address1357, 20200, Kericho, Kenya
        • telephone+254-705-251687
        • emailflynn.alexander@usamru-k.org
        • created2019-03-07 14:40:02
        • modified2020-02-27 08:14:14
    • SiteDetail(array)
      • 0(array)
        • id627
        • application_id771
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-03-07 14:40:02
        • modified2020-02-27 08:14:14
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id375
        • application_id771
        • sponsorMilitary Infectious Diseases Research Program (MIDRP)
        • sponsor_typeResearch Institution
        • contact_personCDR Ramiro Gutierrez
        • addressNavy Medical Research Center
        • telephone_number+1 301-319-3193
        • fax_number
        • cell_number+1 301-319-3193
        • email_addressramiro.l.gutierrez.mil@mail.mil
        • created2019-03-07 14:40:02
        • modified2020-02-27 08:14:14
  • 3(array)
    • Application(array)
      • id767
      • user_id501
      • trial_status_id5
      • abstract_of_study<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">In many rural clinics providing women’s health services, paracervical block is impossible to perform due to the high cost of necessary tools (spinal needle, needle extender). In these situations, women undergo manual vacuum aspiration (MVA) and other gynecologic procedures without paracervical analgesia. We have developed a low-cost, reusable syringe extension device for the provision of paracervical analgesia during MVA. We propose to validate functionality of the device and collect user feedback from women’s health providers and patients at four sites in Kisumu, Kenya.</span></span></p>\n
      • study_title<p>\n <span style=\"font-size:12px;\"><span style=\"font-family: Helvetica;\">Validation of re-usable, low cost syringe extension device for the provision of paracervical analgesia during gynecological procedures</span></span></p>\n
      • laymans_summary<p>\n Women who are having a miscarriage, are usually treated by emptying the uterus. One of the ways to achieve this is a procedure that sucks out the non viable pregnancy called Manual Vacuum Aspiration (MVA) and many in Kenya refer to this procedure with the Kiswahili term "Kuoshwa tumbo".</p>\n<p>\n This procedure causes considerable pain, one way of avoiding pain includes the administration of a numbing injection (LA) to the cervix. However due to the position of the cervix in the birth canal, administration of this injection requires a super long needle that was designed for giving spinal anaesthesia. The unavailability and cost of the spinal needle has led to many women having this procedure with inadequate pain control.</p>\n<p>\n We have invented the Chloe Syringe Extension Device (SED), a low cost reusable gadget, that makes it possible to give a numbing injection to the cervix without needing a spinal needle.</p>\n<p>\n For the purpose of this study, the Chloe SED was manufactured in Nairobi by 3D printing.</p>\n<p>\n In this study we compared pain relief obtained by giving the numbing injection with the spinal needle, to that obtained with our invention.</p>\n<p>\n The results indicate that the pain relief obtained by Chloe SED is the same as that obtained by the spinal needle.</p>\n<p>\n We conclude that Chloe SED is a good substitute to the spinal needle in giving the numbing injection.</p>\n<p>\n We intend to use this results to design a bigger study to establish more information on the suitability of the gadget on giving the numbing injection</p>\n
      • short_titleValidation of syringe extension device
      • protocol_noECCT/19/03/01
      • version_no1.0
      • date_of_protocol01-01-2019
      • study_drugSyringe extension device (new device)
      • disease_conditionAnalgesia for paracervical block
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameSyringe extension device
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressgwerso@yahoo.co.uk
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantStephen Gwer
      • declaration_date111-04-2019
      • declaration_principal_investigatorStephen Gwer
      • declaration_date211-04-2019
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">1.  Health providers providing MVA services at the four study sites. </span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">2.  Female patients receiving MVA at the four study sites </span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">3.  Ability to consent and understand that participation in the study involves potential use of a new device during the planned MVA. </span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">4.  Age greater than 18.</span></span></p>\n
      • principal_exclusion_criteria<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">1.  Males will be excluded from the patient population as men do not receive MVA services. </span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">2.  Male MVA providers will not be excluded from the provider population.</span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">3.  There is no limitation based on race, tribe, or sexual orientation in the study for any patients or providers who meet inclusion criteria. </span></span></p>\n<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">4.  There are no exclusions for patients based on language.</span></span></p>\n
      • primary_end_points<p>\n <span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"font-size:12px;\">To validate the functionality of a newly developed, low-cost, non-invasive syringe extension device for provision of paracervical analgesia during MVA in a proof-of-concept study. Functionality will be assessed via measurement of patient pain levels during MVA utilizing either the syringe extension device (experimental arm) or standard spinal needle (control arm) to administer paracervical analgesia.</span></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology1
      • trial_administration_humans1
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The study population will include women’s health providers who perform MVA and patients requiring manual vacuum aspiration (MVA) at four clinical sites in Kisumu, Kenya: Jaramogi Oginga Odinga Teaching and Referral Hospital, Kisumu County Hospital, Marie Stopes Kenya, and God’s Will Clinic. The study team met with the regional directors at each of the four sites and confirmed willingness of each site to participate in the study (letters of support included). Clinical volume and number of MVA providers at each site were confirmed to ensure an adequate number of potential study participants for recruitment within the study period. Average clinical volume between the five sites is 400 MVA procedures per month with approximately 20 MVA providers available for potential study recruitment. </span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Jaramogi Oginga Odinga Teaching and Referral Hospital has a maternity complex with 60 beds. MVA providers at this facility include medical officers (MO) and clinical officers (CO). Other providers staffing the ward including Ob/Gyn physicians, residents, and nursing staff. There is a procedure room available for MVA procedures and an operating theatre also available. Kisumu County Hospital has a gyne ward with 6 beds. A procedure room is available for MVA procedures. MVA procedures are completed by nurses and COs. Marie Stopes International provides family planning services including post-abortion care in 37 countries worldwide. In Kenya, there are 23 centres, including the study site in Kisumu. At this site, MVA providers include nurses and COs in a procedure room. God’s Will Clinic in Kisumu provides MVA and post-abortion care. MVA procedures are conducted by nurses and CO in a procedure room.</span></span></p>\n
      • other_details_explanation<p>\n The trial is to be conducted in Kenya which is the host country of the applicant. The syringe extender has been developed in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n University of Illinois at Chicago Ethical Review Board: preliminary approval granted with one minor modification: February 27,2019</p>\n
      • other_details_regulatory_approved<p>\n Maseno University Ethical Review Board (MUERC): February 18, 2019</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration5 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorParacervical block admini
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites4
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteCompetitive enrollment - minimum of zero and maximum of 60 at each site
      • total_participants_worldwide60
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameStephen
      • investigator1_middle_name
      • investigator1_family_nameGwer
      • investigator1_qualificationMedical Doctor - Obstetrics and Gynecology
      • investigator1_professional_addressPrivate Bag, Maseno University School of Medicine, Kisumu, Kenya
      • investigator1_telephone+254 77 2657163
      • investigator1_emailgwerso@gmail.com
      • organisations_transferred_No
      • number_participants60
      • notification<p>\n We look forward to your favourable response</p>\n
      • approval_date01-08-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted02-05-2019
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n <strong><em>Introduction:</em></strong> This was a pilot study that evaluated the efficacy of a novel, ultra-low-cost syringe extension device SED, which we have now decided to name the Chloe SED for provision of paracervical block (PCB) during manual vacuum aspiration (MVA). </p>\n<p>\n <strong><em>Method</em></strong>: A randomized, single-blinded non-inferiority trial of 61 patients was conducted at two facilities in Kisumu between September 2019 and January 2021 comparing PCB administered with Chloe-SED to a standard spinal needle.  The primary outcome was non-inferiority of pain score during uterine evacuation within a non-inferiority margin of 2 points on an 11-point visual assessment scale.  Secondary outcomes included non-inferiority of pain score at 4 other time points, patient satisfaction, and provider feedback on Chloe-SED.</p>\n<p>\n <strong><em>Results</em></strong>: Chloe-SED showed non-inferiority of the primary outcome with mean pain score during evacuation of 3.9 (3.2-4.7) compared with spinal needle at 4.1 (3.5-4.7).  Non-inferiority was shown at all time points. In one patient the syringe and device were incompatible.  The only adverse event was breakage of the finger-pad of the device after completion of PCB with no injury to patient or provider. Most patients and providers expressed desire for continued use of the device to administer PCB for MVA. </p>\n<p>\n <strong><em>Conclusion</em></strong>: The Chloe SED device appears effective and desirable for administration of PCB during MVA.</p>\n<p>\n <strong><em>Introduction:</em></strong> This was a pilot study that evaluated the efficacy of a novel, ultra-low-cost syringe extension device (Chloe-SED) for provision of paracervical block (PCB) during manual vacuum aspiration (MVA). </p>\n<p>\n <strong><em>Method</em></strong>: A randomized, single-blinded non-inferiority trial of 61 patients was conducted at two facilities in Kisumu between September 2019 and January 2021 comparing PCB administered with Chloe-SED to a standard spinal needle.  The primary outcome was non-inferiority of pain score during uterine evacuation within a non-inferiority margin of 2 points on an 10-point visual assessment scale.  Secondary outcomes included non-inferiority of pain score at 4 other time points, patient satisfaction, and provider feedback on Chloe-SED.</p>\n<p>\n <strong><em>Results</em></strong>: Chloe-SED showed non-inferiority of the primary outcome with mean pain score during evacuation of 3.9 (3.2-4.7) compared with spinal needle at 4.1 (3.5-4.7).  Non-inferiority was shown at all time points. In one patient the syringe and device were incompatible.  The only adverse event was breakage of the finger-pad of the device after completion of PCB with no injury to patient or provider. Most patients and providers expressed desire for continued use of the device to administer PCB for MVA. </p>\n<p>\n <strong><em>Conclusion</em></strong>: The Chloe SED device appears effective and desirable for administration of PCB during MVA.<strong><em> </em></strong>This results will be important in designing a larger more powered validation trial</p>\n
      • implication_results<p>\n These findings imply that Chloe SED is a suitable substitute to the spinal needle for provision of paracervical block. It therefore implies, that in situations where a spinal needle is not available it is possible to give adequate analgesia at no additional cost to the patient.</p>\n
      • quantity_importedNone all the syringe extension devices were manufactured in Nairobi
      • quantity_dispensedAll 30 devices were used and are available.
      • quantity_destroyednone was destroyed, but some broke and all are available.
      • quantity_exportednone
      • balance_site30
      • final_date0000-00-00
      • modified2025-08-22 22:30:09
      • created2019-02-27 09:02:06
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id476
        • application_id767
        • given_nameStephen
        • middle_name
        • family_nameGwer
        • qualificationMedical doctor - Obstetrics and Gynecology
        • professional_addressPrivate Bag, Maseno University School of Medicine, Kisumu, Kenya
        • telephone+254 77 2657163
        • emailgwerso@gmail.com
        • created2019-02-27 18:30:16
        • modified2019-05-02 23:32:03
      • 1(array)
        • id477
        • application_id767
        • given_nameAparna
        • middle_name
        • family_nameRamanathan
        • qualificationMedical Doctor - Obstetrics and Gynecology and Device Co-Inventor
        • professional_address820 S Wood Street, University of Illinois at Chicago School of Medicine, Chicago, IL, USA
        • telephone+1 617 388 8643
        • emailaparna.rajam@gmail.com
        • created2019-02-27 18:34:25
        • modified2019-05-02 23:32:03
    • SiteDetail(array)
      • 0(array)
        • id613
        • application_id767
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressKisumu-Kakamega Road
        • contact_details+254 057 2020801
        • contact_personDr. Okoth Peter, Dr. Stephen Gwer
        • site_capacity(null)
        • misc(null)
        • created2019-02-27 18:30:16
        • modified2019-05-02 23:32:03
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id614
        • application_id767
        • county_id42
        • site_nameKisumu County Hospital
        • physical_addressOff Ang\'awa Avenue Box 1818
        • contact_details+254 057 2020171
        • contact_personDr. Massawa T.J., Dr. Stephen Gwer
        • site_capacity(null)
        • misc(null)
        • created2019-02-27 18:59:04
        • modified2019-05-02 23:32:03
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id615
        • application_id767
        • county_id42
        • site_nameGod\'s Will Clinic
        • physical_addressRing Road
        • contact_details+254 0925248766
        • contact_personJanet A. Ogutu, Dr. Stephen Gwer
        • site_capacity(null)
        • misc(null)
        • created2019-02-27 18:59:04
        • modified2019-05-02 23:32:03
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 3(array)
        • id616
        • application_id767
        • county_id42
        • site_nameMarie Stopes Kenya-Kisumu Clinic
        • physical_addressJomo-Kenyatta Highway
        • contact_details+254 800 720 005
        • contact_personDaisy Adalla, Dr. Stephen Gwer
        • site_capacity(null)
        • misc(null)
        • created2019-02-27 18:59:04
        • modified2019-05-02 23:32:03
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id372
        • application_id767
        • sponsorDepartment of Obstetrics and Gynecology
        • sponsor_type(null)
        • contact_personAparna Ramanathan
        • address820 S Wood Street, University of Illinois at Chicago School of Medicine, Chicago, IL, USA
        • telephone_number+1 617 388 8643
        • fax_number
        • cell_number+1 617 388 8643
        • email_addressaparna.rajam@gmail.com
        • created2019-02-27 18:30:16
        • modified2019-05-02 23:32:03
  • 4(array)
    • Application(array)
      • id756
      • user_id693
      • trial_status_id7
      • abstract_of_study<div>\n Short Title: An open label, single arm study of the safety and efficacy of DTG/3TC in therapy-naïve HIV-1 infected adolescents.</div>\n<div>\n  </div>\n<div>\n Rationale: The combination of DTG plus 3TC is under investigation in 2 large, randomized, double-blind, active controlled clinical trials in adult participants (Studies 204861 and 205543). Data from this trial is intended to supplement the dataset in adults with data in adolescents. As such, data from this trial will provide ‘bridging’ information for regulatory authorities and treating clinicians. </div>\n<div>\n  </div>\n<div>\n Objectives: The primary objective of the study is to assess the antiviral activity of DTG/3TC in antiretroviral naïve HIV-1 infected adolescents. The endpoint in measured by the proportion of participants with plasma HIV-1 RNA less than 50 c/mL at Week 48 using the Snapshot algorithm (ITT-E population). The secondary objectives include: assessment of early antiviral activity of DTG/3TC and determination of extended long term (≥48 weeks) safety, tolerability, and viral response of DTG/3TC in antiretroviral-naïve HIV-1 infected adolescents. To evaluate the effect of DTG/3TC on immunologic response from baseline to 24 and 48 weeks. To assess the safety and tolerability of DTG/3TC in HIV-1 infected adolescents at 24 and 48 weeks. To assess DTG and 3TC exposure and to evaluate the steady-state pharmacokinetics of DTG and 3TC in HIV-1 infected adolescents. To assess development of viral resistance to DTG and 3TC in participants experiencing protocol-defined virologic failure (i.e. meeting confirmed virologic withdrawal criteria).</div>\n<div>\n  </div>\n<div>\n Overall Design: This is an open label, single arm, 48-week assessment of the fixed dose combination of DTG/3TC in HIV-1 infected, antiretroviral-naïve adolescents.</div>\n<div>\n  </div>\n<div>\n Number of Participants: This study will be conducted in approximately 30 HIV-1 infected, treatment naïve adolescent participants with screening plasma HIV-1 RNA ≤500,000 c/mL. Approximately 40 participants will be screened to enable enrolment of approximately 30 participants.</div>\n<div>\n  </div>\n<div>\n Treatment Groups and Duration: All participants will receive the fixed dose combination of DTG/3TC (50/300 mg) for once daily dosing. After a screening period of up to 28 days, all participants will be treated for 48-weeks. Participants who successfully complete 48 weeks of therapy and continue to benefit from this two-drug regimen may enter a 96-week study extension phase. Participants who successfully complete the extension phase and continue to receive benefit will have access to this regimen until it is available locally.</div>\n<div>\n  </div>\n<div>\n Analysis: The primary endpoint of the proportions of participants meeting the criteria for virologic success as defined by the US Food and Drug Administration (FDA) snapshot algorithm will be reported with exact Clopper Pearson 95% confidence intervals. Safety analyses will be summarized by visit.</div>\n<div>\n  </div>\n
      • study_title<p>\n An Open-Label, Single Arm Study to Evaluate the Week 48 Efficacy and Safety of a Two-Drug Regimen of Dolutegravir/Lamivudine (DTG/3TC) as a Fixed Dose Combination (FDC), in Antiretroviral Therapy (ART)-Naive HIV-1-Infected Adolescents, ≥12 To <18 Years of Age who Weigh at Least 40 Kg.</p>\n
      • laymans_summary<p>\n Protocol Title: An open-label, single arm study to evaluate the week 48 efficacy and safety of a two-drug regimen of dolutegravir/lamivudine (DTG/3TC) as a fixed dose combination (FDC), in antiretroviral therapy (ART)-naive HIV-1-infected adolescents, 12 to <18 years of age who weigh at least 40 kg.<br />\n Short Title: An open label, single arm study of the safety and efficacy of DTG/3TC in therapy-naïve HIV-1 infected adolescents.<br />\n Rationale: The combination of DTG plus 3TC is under investigation in 2 large, randomized, double-blind, active controlled clinical trials in adult participants (Studies<br />\n 204861 and 205543). Data from this trial is intended to supplement the dataset in adults with data in adolescents. As such, data from this trial will provide ‘bridging’ information for regulatory authorities and treating clinicians. The dual combination of DTG plus 3TC will be assessed in pediatric participants 2 to <12 years of age in a separate planned study.</p>\n<p>\n <strong>Objectives and Endpoints</strong></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:301px;\">\n <p>\n <strong>Objective</strong></p>\n </td>\n <td style=\"width:301px;\">\n <p>\n <strong>Endpoint</strong></p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:601px;\">\n <p>\n <strong>Primary</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n Primary</p>\n <p>\n To assess the antiviral activity of DTG/3TC in antiretroviral naïve HIV-1 infected adolescents.</p>\n </td>\n <td style=\"width:301px;\">\n <p>\n The proportion of participants with plasma HIV-1 RNA less than 50 c/mL at Week 48 using the Snapshot algorithm (ITT-E population).</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:601px;\">\n <p>\n <strong>Secondary</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n To assess the early antiviral activity of DTG/3TC and to determine the extended long term (≥48 weeks) safety, tolerability, and viral response of DTG/3TC in antiretroviral naïve HIV-1 infected adolescents.</p>\n </td>\n <td style=\"width:301px;\">\n <ul>\n <li>\n Proportion of participants with plasma HIV-1 RNA <200 and <50 copies/mL at Week 24, Week 96 and Week 144.</li>\n <li>\n Proportion of participants with plasma HIV-1 RNA <200 copies/mL at Week 48</li>\n <li>\n Incidence and severity of AEs and</li>\n <li>\n laboratory abnormalities through 144 weeks</li>\n <li>\n Proportion of participants who discontinue treatment due to AEs through 144 weeks</li>\n <li>\n Safety and tolerability assessments at Weeks 96 and 144.</li>\n <li>\n Viral load monitoring after Week 48 through Week 144.</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n To evaluate the effect of DTG/3TC on immunologic response from baseline to 24 and 48 weeks</p>\n <p>\n  </p>\n <p>\n  </p>\n </td>\n <td style=\"width:301px;\">\n <ul>\n <li>\n Change from baseline in CD4+ and CD8+ cell count and ratio at Week 24 and 48.</li>\n <li>\n Incidence of disease progression (HIV associated conditions, acquired immunodeficiency syndrome (AIDS), and death) through Weeks 24 and 48</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n To assess the safety and tolerability of</p>\n <p>\n DTG/3TC in HIV-1 infected adolescents at 24 and 48 weeks</p>\n <p>\n  </p>\n </td>\n <td style=\"width:301px;\">\n <ul>\n <li>\n Incidence and severity of AEs and laboratory abnormalities through 24 and 48 weeks</li>\n <li>\n Proportion of participants who discontinue treatment due to AEs through 24 and 48 weeks</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n To assess DTG and 3TC exposure and to evaluate the steady-state pharmacokinetics of DTG and 3TC in HIV-1 infected adolescents</p>\n <p>\n  </p>\n </td>\n <td style=\"width:301px;\">\n <ul>\n <li>\n Steady-state plasma PK parameters of DTG and 3TC will be assessed using intensive PK collected in a subset of participants.</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n To assess development of viral resistance to DTG and 3TC in participants experiencing protocol-defined virologic failure (i.e. meeting confirmed virologic withdrawal criteria).</p>\n <p>\n  </p>\n </td>\n <td style=\"width:301px;\">\n <p>\n Incidence of observed genotypic and</p>\n <p>\n phenotypic resistance to DTG and 3TC for participants meeting confirmed virologic withdrawal criteria.</p>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n Overall Design: This is an open label, single arm, 48-week assessment of the fixed dose combination of DTG/3TC in HIV-1 infected, antiretroviral naïve adolescents.<br />\n Number of Participants: This study will be conducted in approximately 30 HIV-1 infected, treatment naïve adolescent participants with screening plasma HIV-1 RNA<br />\n 500,000 c/mL. Approximately 40 participants will be screened to enable enrolment of approximately 30 participants.<br />\n Treatment Groups and Duration: All participants will receive the fixed dose combination of DTG/3TC (50/300 mg) for once daily dosing. After a Screening Period of<br />\n up to 28 days, all participants will be treated for 48-week Treatment Phase. Participants who successfully complete 48 weeks of therapy and who continue to receive benefit from this two-drug regimen may enter a 96-week study Extension Phase. Participants who successfully complete the Extension Phase and who continue to receive benefit from this two-drug regimen will have access to this regimen until it is available locally.<br />\n Analysis: The primary endpoint of the proportions of participants meeting the criteria for virologic success as defined by the US Food and Drug Administration (FDA) snapshot algorithm will be reported with exact Clopper Pearson 95% confidence intervals. Safety analyses will be summarized by visit.</p>\n
      • short_title DANCE Study
      • protocol_noECCT/19/02/01
      • version_no2017N326062_01/205861 Version 02 Ammendment 1
      • date_of_protocol13-06-2018
      • study_drugDTG+3TC FDC
      • disease_conditionHIV/AIDS
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameDolutegravir
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressfotieno@nrhskenya.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Fredrick Odhiambo Otieno
      • declaration_date104-02-2019
      • declaration_principal_investigatorDr Fredrick Odhiambo Otieno
      • declaration_date206-02-2019
      • placebo_presentNo
      • study_objectives<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:301px;\">\n <p>\n <strong>Objective</strong></p>\n </td>\n <td style=\"width:301px;\">\n <p>\n <strong>Endpoint</strong></p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:601px;\">\n <p>\n <strong>Primary</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n Primary</p>\n <p>\n To assess the antiviral activity of DTG/3TC in antiretroviral naïve HIV-1 infected adolescents.</p>\n </td>\n <td style=\"width:301px;\">\n <p>\n The proportion of participants with plasma HIV-1 RNA less than 50 c/mL at Week 48 using the Snapshot algorithm (ITT-E population).</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"2\" style=\"width:601px;\">\n <p>\n <strong>Secondary</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n To assess the early antiviral activity of DTG/3TC and to determine the extended long term (≥48 weeks) safety, tolerability, and viral response of DTG/3TC in antiretroviral naïve HIV-1 infected adolescents.</p>\n <p>\n  </p>\n </td>\n <td style=\"width:301px;\">\n <ul>\n <li>\n Proportion of participants with plasma HIV-1 RNA <200 and <50 copies/mL at Week 24, Week 96 and Week 144.</li>\n <li>\n Proportion of participants with plasma HIV-1 RNA <200 copies/mL at Week 48</li>\n <li>\n Incidence and severity of AEs and</li>\n <li>\n laboratory abnormalities through 144 weeks</li>\n <li>\n Proportion of participants who discontinue treatment due to AEs through 144 weeks</li>\n <li>\n Safety and tolerability assessments at Weeks 96 and 144.</li>\n <li>\n Viral load monitoring after Week 48 through Week 144.</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n To evaluate the effect of DTG/3TC on immunologic response from baseline to 24 and 48 weeks</p>\n <p>\n  </p>\n <p>\n  </p>\n </td>\n <td style=\"width:301px;\">\n <ul>\n <li>\n Change from baseline in CD4+ and CD8+ cell count and ratio at Week 24 and 48.</li>\n <li>\n Incidence of disease progression (HIV associated conditions, acquired immunodeficiency syndrome (AIDS), and death) through Weeks 24 and 48</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n To assess the safety and tolerability of DTG/3TC in HIV-1 infected adolescents at 24 and 48 weeks</p>\n </td>\n <td style=\"width:301px;\">\n <ul>\n <li>\n Incidence and severity of AEs and laboratory abnormalities through 24 and 48 weeks</li>\n <li>\n Proportion of participants who discontinue treatment due to AEs through 24 and 48 weeks</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n To assess DTG and 3TC exposure and to evaluate the steady-state pharmacokinetics of DTG and 3TC in HIV-1 infected adolescents</p>\n </td>\n <td style=\"width:301px;\">\n <ul>\n <li>\n Steady-state plasma PK parameters of DTG and 3TC will be assessed using intensive PK collected in a subset of participants.</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:301px;\">\n <p>\n To assess development of viral resistance to DTG and 3TC in participants experiencing protocol-defined virologic failure (i.e. meeting confirmed virologic withdrawal criteria).</p>\n <p>\n  </p>\n </td>\n <td style=\"width:301px;\">\n <p>\n Incidence of observed genotypic and phenotypic resistance to DTG and 3TC for participants meeting confirmed virologic withdrawal criteria.</p>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <br />\n  </p>\n
      • principal_inclusion_criteria<div>\n Age and weight</div>\n<div>\n 1.<span style=\"white-space:pre\"> </span>HIV-1 infected adolescents 12 to <18 years of age at the time of signing the informed consent form.</div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Weight 40 kg at the time of signing the informed consent form.</div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>Screening plasma HIV-1 RNA between 1,000 and 500,000 c/mL.</div>\n<div>\n  </div>\n<div>\n Type of participant and diagnosis including disease severity</div>\n<div>\n 4.<span style=\"white-space:pre\"> </span>Antiretroviral-naïve (defined as no prior therapy with any antiretroviral agent for the treatment of HIV following a diagnosis of HIV-1 infection).  Participants who received antiretroviral therapy for prevention of mother to child transmission of HIV in the first 3 months of life are allowed.</div>\n<div>\n  </div>\n<div>\n 5.<span style=\"white-space:pre\"> </span>Sex</div>\n<div>\n Male or female.</div>\n<div>\n  </div>\n<div>\n A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at Screening and negative urine hCG test before Enrollment) and not lactating.</div>\n<div>\n  </div>\n<div>\n Female participants who are of child bearing potential and who are engaging in sexual activity that could lead to pregnancy, must agree to use one of the birth control methods listed in Appendix 10 (Section 12.10) from 28 days prior to the first dose of study medication, and until the last dose of study medication and completion of the Follow-up visit (4 weeks after the last dose). Condoms are recommended in addition, because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.</div>\n<div>\n  </div>\n<div>\n The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception.</div>\n<div>\n  </div>\n<div>\n All participants participating in the study should also be counselled on safer sexual practices, including the use and benefit/risk of effective barrier methods (e.g. male condom), and on the risk of HIV transmission to an uninfected partner.</div>\n<div>\n  </div>\n<div>\n 6.<span style=\"white-space:pre\"> </span>Informed consent</div>\n<div>\n The participant’s parent(s) or legal guardian or the participant is capable of giving signed informed consent as described in Section 12.4.3 which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. Where applicable, participants must provide written assent.</div>\n<div>\n  </div>\n
      • principal_exclusion_criteria<div>\n 1.<span style=\"white-space:pre\"> </span>Females who are breastfeeding or plan to become pregnant or breastfeed during the study.</div>\n<div>\n  </div>\n<div>\n 2.<span style=\"white-space:pre\"> </span>Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 and/or Category C or WHO Stage 3 or 4 disease (Appendix 6, Section 12.6), except cutaneous Kaposi’s sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells/mm3 or CD4% <15%.</div>\n<div>\n  </div>\n<div>\n 3.<span style=\"white-space:pre\"> </span>Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification (Section 12.2).</div>\n<div>\n  </div>\n<div>\n 4.<span style=\"white-space:pre\"> </span>Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).</div>\n<div>\n  </div>\n<div>\n 5.<span style=\"white-space:pre\"> </span>Evidence of HBV infection based on the results of testing at Screening for HBV surface antigen (HBsAg), HBV core antibody (anti-HBc), HBV surface antibody (anti-HBs or HBsAb), and HBV DNA as follows:</div>\n<div>\n  </div>\n<div>\n •<span style=\"white-space:pre\"> </span>Participants positive for HBsAg are excluded;</div>\n<div>\n  </div>\n<div>\n •<span style=\"white-space:pre\"> </span>Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.</div>\n<div>\n  </div>\n<div>\n NOTE: Participants positive for anti-HBc (negative HBsAg status) and positive for anti- HBs (past and/or current evidence) are immune to HBV and are not excluded.</div>\n<div>\n  </div>\n<div>\n 6.<span style=\"white-space:pre\"> </span>Anticipated need for any HCV therapy during the first 48 weeks of the study and for HCV therapy based on interferon or any drugs that have a potential for adverse drug:drug interactions with study treatment throughout the entire study period.</div>\n<div>\n  </div>\n<div>\n 7.<span style=\"white-space:pre\"> </span>Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 14 days post completed treatment are eligible.</div>\n<div>\n  </div>\n<div>\n 8.<span style=\"white-space:pre\"> </span>History or sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that in the opinion of the Investigator or Medical Monitor contraindicates participation.</div>\n<div>\n  </div>\n<div>\n 9.<span style=\"white-space:pre\"> </span>Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study Medical Monitor for inclusion of the participant.</div>\n<div>\n  </div>\n<div>\n 10.<span style=\"white-space:pre\"> </span>Participants who in the investigator’s judgment, poses a significant suicidality risk.</div>\n<div>\n Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk.</div>\n<div>\n  </div>\n<div>\n Exclusionary treatments prior to screening or day 1</div>\n<div>\n  </div>\n<div>\n 11.<span style=\"white-space:pre\"> </span> with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.</div>\n<div>\n  </div>\n<div>\n 12.<span style=\"white-space:pre\"> </span>Treatment with any of the following agents within 28 days of Screening </div>\n<div>\n I.<span style=\"white-space:pre\"> </span>radiation therapy,</div>\n<div>\n II.<span style=\"white-space:pre\"> </span>cytotoxic chemotherapeutic agents, </div>\n<div>\n III.<span style=\"white-space:pre\"> </span>any systemic immune suppressant;</div>\n<div>\n 13.<span style=\"white-space:pre\"> </span>Treatment with any agent with documented activity against HIV-1 in vitro within 28 days of first dose of study treatment.</div>\n<div>\n  </div>\n<div>\n 14.<span style=\"white-space:pre\"> </span>Receipt of any prohibited mediation listed in Section 7.9.2 and inability or unwillingness to switch to an alternative medication.</div>\n<div>\n  </div>\n<div>\n 15.<span style=\"white-space:pre\"> </span>Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of study treatment.</div>\n<div>\n Laboratory values or clinical assessments at screening</div>\n<div>\n  </div>\n<div>\n 16.<span style=\"white-space:pre\"> </span>Any evidence of pre-existing viral resistance based on the presence of any major resistance-associated mutation [International Antiviral Society -USA, 2017] in the Screening result or, if known, in any historical resistance test result.  NOTE: retests of disqualifying Screening genotypes are not allowed.</div>\n<div>\n  </div>\n<div>\n 17.<span style=\"white-space:pre\"> </span>Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening period to verify a result.</div>\n<div>\n  </div>\n<div>\n 18.<span style=\"white-space:pre\"> </span>Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the participant’s participation in the study of an investigational compound.</div>\n<div>\n  </div>\n<div>\n 19.<span style=\"white-space:pre\"> </span>Alanine aminotransferase (ALT) 5 times the upper limit of normal (ULN) or ALT</div>\n<div>\n 3xULN and bilirubin 1.5xULN (with >35% direct bilirubin).</div>\n<div>\n  </div>\n<div>\n 20.<span style=\"white-space:pre\"> </span>Creatinine clearance of <50 mL/min/1.73 m2 using the Schwartz equation method.</div>\n<div>\n  </div>\n
      • primary_end_points<p>\n Determine the proportion of participants with plasma HIV-1 RNA less than 50 c/mL at Week 48 using the Snapshot algorithm (ITT-E population).</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">1. NRHS run UNIM Research and Training center (URTC), a 782 square meter state of the art facility </span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">which was the site of the VMMC randomised controlled trial in Kisumu and is the site for many of its studies. URTC has, a</span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\"> 42 square metre fully equipped laboratory with safety hood, centrifuges, incubators, nitrogen tanks, freezers and all the necessary facilities to process and store specimen for its current studies. There are </span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">3 counselling rooms for consenting, counselling and interviewing, f</span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">our fully equipped examination rooms, </span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">2 fully equipped VMMC operation theatres, one </span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">post operative recovery room and </span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">2 data management rooms. URTC also has an </span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">IT room, a c</span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">onference room, a c</span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">ommon office 26 square metres, a r</span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">ecords room, a h</span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">ygiene and sterilisation room and  a l</span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">aundry. Additionally there is a c</span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">ommunity engagement office, </span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">2 coordination offices, a </span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">reception area and additional basic </span><span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">amenities including 3 toilets and 1 kitchen.</span></p>\n<p>\n <span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">We have 12 staff dedicating time to this study including a project coordinator, nurse coordinator, medical officer, 2 clinical officers, 2 nurse counsellors, a pharmacist, a pharmaceutical technologist, 2 HIv counsellors, a receptionists, driver and 2 research assistants.    </span></p>\n<p>\n 2.Kenya Medical Research Institute, Centre for Global Health Research (KEMRI-CGHR) HIV Research Branch is located at the KEMRI Clinical Research Centre (CRC) within the Jaramogi Oginga Odinga Teaching and Referral Hospital grounds. The site has the following facilities at the CRC:</p>\n<p>\n •CRC main building;</p>\n<p>\n o             Participants Reception managed by two receptionists</p>\n<p>\n o             Participants waiting area with entertainment unit</p>\n<p>\n o             8 clinic rooms, one used for phlebotomy procedures.</p>\n<p>\n o             One Investigational main pharmacy</p>\n<p>\n o             Adolescents waiting room furnished with a table, chairs, with Wi-Fi and computers</p>\n<p>\n o             The first records room for keeping files for participants on active follow up</p>\n<p>\n o             Emergency room</p>\n<p>\n •CRC Clinic building;</p>\n<p>\n o             The second records room used to keep inactive files during before archiving</p>\n<p>\n o             Regulatory/QAQC office</p>\n<p>\n  </p>\n<p>\n •Adolescents Clinic that has;</p>\n<p>\n o             Waiting area with entertainment unit and Wi-Fi </p>\n<p>\n o             3 clinic rooms</p>\n<p>\n o             1 conference room</p>\n<p>\n o             Functional Air Conditioning units</p>\n<p>\n  </p>\n<p>\n •Laboratory</p>\n<p>\n o             2 HIV Research labs, one stationed at the CRC and another at Kisian campus, about half an hour drive from the CRC.</p>\n<p>\n o             Both are well equipped with modern machines and well-trained staff</p>\n<p>\n o             The labs are ISO15189 accredited, listed as WHO prequalification evaluating lab and are DAIDS (Division of Acquired Immune-Deficiency Syndrome) approved</p>\n<p>\n  </p>\n<p>\n External facilities accessible to the site were noted as follows;</p>\n<p>\n  </p>\n<p>\n The HIVR branch has access to the Jaramogi Oginga Odinga Teaching and Referral Hospital, a regional teaching and referral hospital. The branch has a working agreement with the hospital for the following services;</p>\n<p>\n •             Recruitment of participants </p>\n<p>\n •             In-patient services in case the site need admit study participants for care</p>\n<p>\n  </p>\n<p>\n The site has a team of well trained and experienced research staff in the following sections;</p>\n<p>\n  </p>\n<p>\n •             3 - administration officers, two of whom manage the participants reception area</p>\n<p>\n •             1 - Study coordinator</p>\n<p>\n •             3 – Quality Assurance and Quality Control officers</p>\n<p>\n •             7 - Community interviewers/Recruitment team</p>\n<p>\n •             2 - Behavioral science specialists</p>\n<p>\n •             3 - Medical officers (Co-investigators)</p>\n<p>\n •             3 - Clinical officers</p>\n<p>\n •             4 - Registered nurses/nurse counselors</p>\n<p>\n •             3 - Pharmacists</p>\n<p>\n •             1 - Regulatory officer</p>\n<p>\n •             1 - Statistician</p>\n<p>\n •             3 – Data Manager/officers</p>\n<p>\n •             1 - Head of HIV Research (Investigator)</p>\n<p>\n •             32 – lab staff</p>\n<p>\n  </p>\n<p>\n The site will begin to prepare the Delegation of Responsibilities Log once the site is approved and the template for the Delegation Log has been received.</p>\n<p>\n  </p>\n<p>\n The Monitor noted the following equipment available at the site;</p>\n<p>\n  </p>\n<p>\n The site is well equipped to run any research study. Of specific interest to the Adolescent study are equipment in the following sections;</p>\n<p>\n  </p>\n<p>\n • Clinic</p>\n<p>\n o             Electrocardiogram</p>\n<p>\n o             Emergency crash cart – updated every month </p>\n<p>\n o             BP machines – both manual and electronic </p>\n<p>\n o             HIV test kits</p>\n<p>\n o             Pregnancy test kits</p>\n<p>\n o             Thermometers</p>\n<p>\n o             Examination couches</p>\n<p>\n o             Weighing scales</p>\n<p>\n o             Stethoscopes</p>\n<p>\n o             Defibrilator</p>\n<p>\n  </p>\n<p>\n •  Laboratory</p>\n<p>\n  </p>\n<p>\n The Laboratory is well equipped with modern machines as specified on the laboratory supervisor's presentation at the Pre-Study Visit Meeting and as noted during the facility tour.</p>\n<p>\n  </p>\n<p>\n • Pharmacy</p>\n<p>\n  </p>\n<p>\n o             1- Certified Chemo shield for chemotherapy preparations</p>\n<p>\n o             1 - Certified biosafety cabinet hood for aseptic preparations</p>\n<p>\n o             3 - Serviced and functional air conditioners; of this 2 are in the main pharmacy</p>\n<p>\n o             3 - Certified Thermo Scientific Fridges 2⁰c - 8⁰c</p>\n<p>\n o             2 - Certified Thermo scientific Freezers -15⁰ -  -25⁰c</p>\n<p>\n o             1 - Certified VWR Freezer -80⁰c</p>\n<p>\n o             Eltek Data logger, that records temperature on the fridges, freezers and room temperature automatically, and capable of sending text message to pharmacy staff in case of looming cold chain break</p>\n<p>\n o             4 - Desktop computers that act as the pharmacy staff working station</p>\n<p>\n o             2- Printers / scanners, able to print out participant labels and other study documents</p>\n<p>\n o             Adequate lockable cabinets to store investigational products with an ample space separately assigned for quarantine</p>\n<p>\n o             The pharmacy is accessible to 6 clinical rooms via hatches that open into adjacent clinician rooms.</p>\n<p>\n o             2- Lockable book cabinets for storage of study binders and study participant folders</p>\n<p>\n o             1- Fireproof safe cabinet for storage of participant identifiable randomization documents</p>\n<p>\n  </p>\n<p>\n Access to the pharmacy is limited by a biometric door access system customized to pharmacy staff only, and therefore limiting unauthorized access).</p>\n<p>\n  </p>\n<p>\n PI and staff are qualified by education, training and experience to properly conduct the.</p>\n<p>\n The site confirmed they have IATA training, experience with Medidata Rave, CITI training (HSP and GCP) and GLP training for all lab staff.</p>\n<p>\n They have experience with HIV and TB clinical studies, both phase 2 and 3 and surveys.</p>\n<p>\n They have participated in a number of Industry-sponsored studies with different sponsors (including GSK and ViiV) under similar indication and profile of patients.</p>\n<p>\n 3. KERICHO SITE AND POPULATION DESCRIPTION</p>\n<p>\n The U.S. Army Medical Research Directorate-Africa (USAMRD-A) is a Special Foreign Activity of the Walter Reed Army Institute of Research (WRAIR), Washington, DC.</p>\n<p>\n USAMRD-A is affiliated through a Cooperative Agreement with the Kenya Medical Research Institute (KEMRI). The unit was activated on a temporary basisin1969 at the invitation of the GovernmentofKenyatostudytrypanosomiasis.Thesuccessofthatinitialventureledtothe establishment of a permanent activity in1973.Over the past46 years, research has been conducted on malaria, trypanosomiasis, leishmaniasis, entomology, HIV/AIDS and arboviruses, with more than 250 manuscripts published.</p>\n<p>\n The USAMRD-A HIV Program is a component of the U.S. Military HIV Research Program (USMHRP). In Kenya, the HIV Program field site is located at the Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP CRC) about 260kilometers North West of Nairobi along the Nairobi-Kisumu highway in the rural Kenyan town of Kericho. Kericho County’s population is approximately 900,000, although the larger catchment area for both HIV research and treatment is approximately 2.7 million covering the Southern portion of the former Rift Valley Province.</p>\n<p>\n Kericho town is located among the Kenyan Highlands in the Rift Valley and well known for the growing of tea that forms the rolling “seas of green” within the tea plantations.  Kiswahili is most spoken language within the town.</p>\n<p>\n  The primary industry in this region is tea farming, with two large international tea companies namely Finlay’s Kenya Ltd. And Unilever Tea Kenya Ltd. Being centered in Kericho County. Kericho was ranked as the twentieth richest County in Kenya in the 2005/06 National Integrated Household Budget Survey. Income in Kericho comes mainly from agricultural activities, with about40-50% of the population living below the poverty line. The annual national gross domestic product per capita in 2005 averaged Kenyan shilling (Ksh) 35,045 (equivalent to 350 United States dollar (USD) at current exchange rates of 1 USD=Ksh100). In Kenya, the age of majority (i.e. Legal age of recognized adulthood or independence) is18years. The Kenyan national literacy level according the Kenya Adult Literacy Survey report published in March 2007 by the Kenya National Bureau of Statistics was 64%.In Kericho, the literacy level is 74.3% in men and 68.9% in women.</p>\n<p>\n The Kericho CRC, established in 1998, is located 260km North West of Nairobi in Kericho town on the grounds of the Ministry of Health, Kericho County Referral Hospital. USAMRD-A has been in Kenya for 46years and has partnered with KEMRI since 1980.  KEMRI is a Government of Kenya Para-state Corporation responsible for health research. The CRC has three integrated main components: HIV care, HIV and micro biology research.  Since 2003 the CRC has been conducting diverse studies including randomized, double-blind, placebo controlled and IND/FDA-regulated studies.</p>\n<p>\n The CRC has 181 local and one U.S. staff with appropriate trainings to support the clinical trials and HIV care and treatment programs. The staff includes; 10doctors, 3pharmacists, 12clinical   officers, 25nurses, 36 laboratory technologists and 6 accountants among others. The CRC has a Community Advisory Board, strong community engagement programs, efficient participant recruitment, retention and follow-up processes. The CRC protocols are reviewed by the KEMRI and WRAIRIRBs.</p>\n<p>\n The  CRC’s, secure  physical infrastructure includes: 1) 13,400 square feet (sq. ft.) clinical research building for reception, waiting areas, clinical procedures, consultation, sample collection, pharmacy, quality assurance, IT servers, data entry, participants’ chart archives, and samplestorage,2)26,115sq.ft.Laboratory space,3)twoliquidnitrogenplants,4) four back-up generators 5) 13,500 sq. ft. administration and 6) 6,000 sq. ft. store. </p>\n<p>\n Both the CRC pharmacy and laboratory are approved by the National Institute of Allergy and Infectious Diseases/ Division of AIDS (NIAID/DAIDS) to participate in DAIDS sponsored vaccine (Site#1502) and the rapeutics (Site#12501) and International Maternal, Pediatric, and Adolescent AIDS Clinical Trials (IMPAACT) Group (Site#5121) studies, the only research site with such approval in Kenya. The laboratory is also College of American Pathologists (CAP) accredited and consists of three main sections: HIV, Microbiology and Mycobacterium Tuberculosis (TB).</p>\n<p>\n  </p>\n<p>\n The KEMRI/WRPCRC research activities are integrated with a large comprehensive public health HIV care, treatment and prevention program managed by KEMRI/WRP and supported by PEPFAR which covers a population of about 2.7 million people in the SRV which is also the CRC research catchment area. Elements supported by the program includes: Antiretroviral Therapy (ART),non-ART,TB/HIV co-infections, Prevention of Mother To Child Transmission of HIV(PMTCT),HIV Testing and Counseling Services(HTS),primary HIV infection prevention in both low and high-risk populations, Orphans and Vulnerable Children (OVC), and Voluntary Medical Male  Circumcision (VMMC). Kenya had an estimated population in 2012 of 43million people, 22% of whom are urban and with an annual population growth rate of 2.4%. The adult (15-64years) HIV/AIDS prevalence rate is 5.6% (6.9% in women, and 4.4% in men). HIV prevalence among children aged18 month’s to14 years was 0.9%.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p style=\"margin-left:5.0pt;\">\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <span style=\"color: rgb(0, 0, 0); font-family: Muli; font-size: 16px;\">   </span></p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n South African Health Products Regulatory Authority; Submitted 22 June 2018; Under Review</p>\n
      • other_details_regulatory_approved<p>\n THAILAND: Drug Control Division of the Food and Drug Administration, 15 August 2018, Approved</p>\n<p>\n UNITED STATES OF AMERICA: Food and Drug Administration, Approved</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites2
      • multi_country_listKenya, South Africa, Thailand and United States of America
      • data_monitoring_committeeYes
      • total_enrolment_per_siteAprox 7+
      • total_participants_worldwide30
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameFredrick
      • investigator1_middle_nameOdhiambo
      • investigator1_family_nameOtieno
      • investigator1_qualificationDCMS, MPH, PhD
      • investigator1_professional_addressUNIM Research and Training Centre
      • investigator1_telephone+254 721 759867
      • investigator1_emailFOtieno@nrhskenya.org
      • organisations_transferred_Yes
      • number_participants15
      • notification<p>\n The following site included in this application have not yet recieved EC approval</p>\n<p>\n The Site teams will notify PPB of the EC notification of approval once recieved prior to commencing study activities.</p>\n<p>\n 1. Dr. Isaac Tsikhutsu</p>\n<p>\n Kenya Medical Research Institute (KEMRI)/</p>\n<p>\n United States Army Medical Research Directorate-Kenya (USAMRD_K)/</p>\n<p>\n Henry Jackson Foundation Medical Research International (HJFMRI),</p>\n<p>\n Hospital Road, Kericho.</p>\n<p>\n 2. Dr. Victor Mudhune</p>\n<p>\n Kenya Medical Research Institute,</p>\n<p>\n Kisumu Clinical Research Centre</p>\n<p>\n Jaramogi Oginga Odinga Teaching and Referral Hospital, off Kisumu-Kakamega Road.</p>\n<p>\n P.O. BOX 1578-40100,</p>\n<p>\n KISUMU,KENYA.</p>\n<p>\n  </p>\n<p>\n PO Box 1357-20200</p>\n<p>\n Kericho</p>\n
      • approval_date14-08-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report
      • implication_results
      • quantity_imported185 bottles of Dolutegravir/Lamivudine 50/300mg (30 Tabs per bottle)
      • quantity_dispensed111 bottles of Dolutegravir/Lamivudine 50/300mg (30 Tabs per bottle)
      • quantity_destroyedTo be destroyed
      • quantity_exportedNone
      • balance_site74 intact bottles of Dolutegravir/Lamivudine 50/300mg (30 Tabs per bottle) plus 262 returned Tablets of Dolutegravir/Lamivudine 50/300mg
      • final_date0000-00-00
      • modified2025-10-13 08:19:16
      • created2019-02-04 08:46:49
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id469
        • application_id756
        • given_nameFredrick
        • middle_nameOdhiambo
        • family_nameOtieno
        • qualificationDCMS, MPH, PhD
        • professional_addressUNIM Research and Training Centre
        • telephone+254 721 759867
        • emailFOtieno@nrhskenya.org
        • created2019-02-04 08:47:35
        • modified2020-06-18 12:54:29
      • 1(array)
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        • application_id756
        • given_nameIsaac
        • middle_name
        • family_nameTsikhutsu
        • qualificationMBChB, MMED
        • professional_addressKenya Medical Research Institute (KEMRI)/ United States Army Medical Research Directorate-Kenya (USAMRD_K)/ Henry Jackson Foundation Medical Research International (HJFMRI)
        • telephone+2542729303
        • emailIsaac.Tsikhutsu@usamru-k.org
        • created2019-04-10 21:50:14
        • modified2020-06-18 12:54:29
    • SiteDetail(array)
      • 0(array)
        • id593
        • application_id756
        • county_id42
        • site_nameNyanza Reproductive Health Society
        • physical_addressUNIM Research and Training Centre, inside Lumumba sub county Hospital
        • contact_detailsP. O. Box 1764 Kisumu 40100
        • contact_personDr Fredrick Otieno
        • site_capacity(null)
        • misc(null)
        • created2019-02-04 08:47:35
        • modified2020-06-18 12:54:29
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          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
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        • county_id42
        • site_nameKenya Medical Research Institute
        • physical_addressKEMRI/CDC Clinical Research Centre, inside Jaramogi Oginga Odinga Teaching and Referral hospital
        • contact_detailsP. O. Box 1578 Kisumu 40100
        • contact_personDr Victor Mudhune
        • site_capacity(null)
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        • created2019-02-04 09:35:25
        • modified2020-06-18 12:54:29
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          • id42
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          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
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        • application_id756
        • county_id35
        • site_nameKenya Medical Research Institute, Walter Reed Project
        • physical_addressWRP Clinical Research Centre, inside Kericho County Referral Hospital
        • contact_detailsP.O. Box 1357 Kericho 20200
        • contact_personDr Isaac Tsikhutsu
        • site_capacity(null)
        • misc(null)
        • created2019-02-04 09:35:25
        • modified2020-06-18 12:54:29
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
    • Sponsor(array)
      • 0(array)
        • id365
        • application_id756
        • sponsorViiV Healthcare Company
        • sponsor_typeIndustry
        • contact_personMonica Lopez
        • addressViiV Healthcare, 27709980 Great West Road, Brentford, Middlesex,TW8 9GS, United Kingdom
        • telephone_number+ 1 919 483 9955
        • fax_numberwww.ppdi.com
        • cell_number+1 919 483 9955
        • email_addressmonica.c.lopez@viivhealthcare.com
        • created2019-02-04 08:47:35
        • modified2020-06-18 12:54:29
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    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php